Q1 2023 Aptose Biosciences Inc Earnings Call
[music].
Yeah.
Okay.
Good afternoon.
My name is Antoine Alexandria, and I'll be your conference operator today.
Would like to welcome everyone to the apples Biosciences reports results for the first quarter ended March 31 2023.
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Now like to introduce MS. Susan Petro Paolo. Please go ahead.
Thank you Angela and good afternoon, and welcome to the <unk> Biosciences conference call to discuss financial and operational results for the first quarter ended March 31st 2023 earlier today. After its issued a press release relating to this financial results news release as well as related SEC filings are accessible on <unk> website.
Joining me on today's call are Dr. William G Rice, Chairman, President and CEO , Dr. Rafael Bejar, Senior Vice President Chief Medical Officer, and Mr. Fletcher Payne Senior Vice President and Chief Financial 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 or Canadian Securities laws forward looking statements reflect <unk> current expectations regarding future events. They are not guarantees of performance and it is possible that actual results and performance could differ materially from these stated.
Expectations.
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 after this most recent annual report on Form 10-K, and SEC filings.
Forward looking statements made during this call speak only as of the date, they're made after 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 Amtrust Biosciences, Dr. Rice.
Thank you Susan.
I want to welcome everyone to our call for the first quarter ended March 31 2023.
Frankly, our year end conference call was held just over a month ago. So today, we will provide you with an incremental but important updates plus we also are planning a corporate update around the European Hematology Association or <unk> conference in June where we plan to provide additional data before.
Before I get into the findings with our pipeline I'll remind you again that we continue to tighten our belts.
Efficiently invest our current cash entity essentials related to maintaining key personnel and advancing our key pharmaceutical assets.
As with any biotech company in the current market, we continue to pursue strategies to finance our programs without punitive financing terms that are pervasive in many of todays financings and we continue to pursue partnering activities that can provide strategic support to our programs and we expect to see say more about these topics in the coming days.
So now let's hit the headlines for today.
First the dose escalation and dose exploration trial with touch pad that has been completed and tested patented delivered clinical responses as a monotherapy over four dose levels and very difficult to treat populations of patients with relapsed or refractory AML.
Second dosing of the combination of <unk> and <unk>.
Panetta Clark's referred to as the test bed doublet is underway for relapsed or refractory AML patients and our App debate expansion trial.
Third we already are seeing brisk enrollment okay.
And a monotherapy arm and the test been doublet arm and the App debate expansion trial, and we already have seen early signs of clinical activity.
Fourth the superior safety profile of <unk> continues to be observed, including a reduced risk of model suppression with prolonged dosing.
Fifth continuous dosing with the Luxe Aptonym, yes looks at them with a G. Three formulation is ongoing.
And finally, I'll remind you that we have our annual shareholders meeting planned for May 23rd and just a few weeks.
So having delivered the headlines now want to provide a few details relating to our lead agent suspended.
This oral small molecule kinase inhibitor was licensed from Hanmi pharmaceutical in South Korea.
We took over the development range for Testbed in January of last year, just five quarters ago.
We applaud our partners at Hanmi for creating this remarkable molecule with a unique kinase targeting pattern.
Deniz to deliver clinical findings that inspires to view <unk> as a potentially playing several key roles in the future treatment regimens of patients with AML and potentially other hematologic malignancies.
First patented was created as a once daily oral Milo myeloid kinase inhibitor to treat patients with AML and we continue to be emboldened by what we're seeing with every emerging piece of data.
By targeting all forms of flip three the thick kinase Jack one inject to R. S. K wanted too and the mutant forms, but not the wild type form of kit prospective delivers a kind of multi drug therapy in one tablet.
That can suppress multiple oncogenic pathways that typically lead to disease progression and relapse.
As I mentioned on our last call, we wrapped up a successful dose escalation and dose exploration phase one two trial with tests pattern up or we observed responses across four dose levels and across a broad range of Berry.
And difficult to treat AML patients that had been filled by other therapies.
Testbed nib was remarkably well tolerated.
As a follow on to the dose escalation and dose exploration trial, we initiated the activate phase one two expansion trial during the first quarter of this year.
And the App debate trial, relapsed or refractory AML patients are being treated with <unk> as a monotherapy.
Or with Testbed Burnet o'clock.
Doublet therapy.
With the monotherapy arm to activate expansion trial is designed to confirm monotherapy activity through patient enrichment of certain tastefully defined AML populations.
Including T P 53 mutant patients.
Flit three mutant patients who'd been failed by a prior <unk> inhibitor as supported by FDA fast track designation and the clinically significant response rate to date.
And possibly Ras mutated patients that have emerged as sensitive to Japan to test them.
Our successful monotherapy arm may provide options for accelerated approval of testbed in relapsed or refractory AML.
And while it's too early to glean formal response data from the first set of patients treated with <unk> monotherapy on the App debate trial I can say that we already have begun to see clear anti leukemic activity.
With a combination arm the App debate expansion trial is designed to evaluate <unk> in combination with Vanadic lax. Several weeks ago. We told you that sites have begun patient enrollment on the test been combination.
I'm really pleased to announce today that the rate of accrual in this trial has been far more brisk than expected there is tremendous enthusiasm from investigators and since our last call. We have dosed a number of patients and their test bed doublet combination cohort.
Here too it's too early to draw any firm response conclusions, but thus far during the early weeks of dosing. The Testbed doublet is being well tolerated and we already are observing blast reductions in patients.
Investors' confidence in this trial is due in part to the remarkable safety of the Testbed nib to date.
Happy to confirm that during the most recent safety review held at the end of the first quarter.
Unique safety profile of <unk> continues with no concerning trends.
The importance of a good safety profile cannot be underestimated as we get questions. All the time, especially because several other AML drugs approved or in development may be limited by toxicity caused by the need for high plasma exposure levels and the excess of suppression of a single target required tools.
Their responses.
For example, published reports show that certain <unk> three inhibitors, such as guilt written it.
To achieve clinical responses required plasma exposure levels that cause near complete inhibition of the flip III target in AML cells as measured by a classic plasma inhibitory activity or Pia assay on reported sales.
Unfortunately plasma levels of such a drug that requires complete inhibition of the target, but also be expected to cause excessive the inhibition of the same target in normal cells and leave the toxicities and that's exactly what's observed clinically.
In contrast, <unk> employees, a different strategy to simultaneously suppress a handful of aquagenic timing issues that dry pathway is critical for leukemia Genesis.
Using the same classic P. I assay, we see that the plasma from patients treated with <unk> can deliver near complete inhibition of flip III and stat five.
However, in patients who achieve clinical responses with Testbed nib.
<unk> inhibition of the single target is not required.
Another clinical responses with Testbed and it can be achieved with 50% to 80% inhibition of flit, three and the downstream stat by signaling the.
The differences that Testbed nib can induce clinical responses by incrementally suppressing several oncogenic pathways simultaneously rather than requiring complete inhibition of any one target.
Consequently, testbed appears to achieve clinical responses at lower exposures, thereby avoiding many of the toxicities observed with competing agents.
And it's this favorable safety pattern that differentiates <unk> from its competitors.
I'll also remind you that testbed nib has shown activity in wild type AML, which accounts for 70% of the AML population, thereby significantly expanding the market potential for this drug and this too is a key differentiating feature of Testbed NIM.
We've said it before but testbed nib safety profile with its broad activity makes it the ideal candidate for combination therapy in frontline therapy and that is where we're ultimately moving towards Dr. Bexar will speak more about our plans for <unk> in combination therapy in the treatment of AML in just a moment.
But now just a quick mention of Lux Aptonym, our secondary pipeline program.
Youre aware that our <unk> formulation of <unk> is being administered to AML patients at the 50 milligram dose level, which is roughly equivalent to the 900 milligram dose level of the original <unk> formulation.
We continue to collect PK and safety data and our plan is to escalate dosing to determine if <unk> can deliver greater plasma levels.
Pre clinically look stepped in as an extraordinary molecule and so we're giving the G. Three formulation every chance to succeed.
And finally, I'll mentioned, our planned upcoming milestones as we March toward key catalysts for the year.
First.
Our end of phase one meeting with the U S. FDA as scheduled during the second quarter of this year. The meeting is designed to ensure that we are in agreement on Testbed Nib clinical study parameters and next steps in the development of the test abatement program.
Second around the time of the Hawk Congress in June we plan to present clinical findings to include Testbed in a dose escalation and dose exploration findings and relapsed or refractory AML patients.
And our preliminary findings in patients dosed with monotherapy, Testbed nib, and the test bed doublet and deactivate trial.
Third around the European school of Hematology or E. S. H meeting in October we plan to percent maturing Testbed nib clinical dataset.
Fourth around the 65th annual Society of annual Society of Hematology or Ash annual meeting and Exposition in December we plan to present, an even more robust and more mature clinical dataset with testbed.
And fifth during the first quarter. This year fourth quarter. This year, we plan to discuss strategies for potential future monotherapy accelerated development of Testbed for.
For doublet phase two development of test bed.
And for a pilot triplet development with tests, Ben and Heartworm escalating agent let.
Let me now hand, it over to Dr. Rafael Bejar, our Chief Medical officer to go into more detail about the <unk> clinical trial of <unk> in AML and to go over the clinical plans and timelines with you Ralph.
Thanks, Bill first it's important to remind you in dose escalation and exploration phase of our trial types was able to achieve complete remission and a very ill relapsed or refractory AML patient population, while also being safe well tolerated we can.
<unk> home announced that these are incredibly difficult patients to treat with highly adverse genetic and happy genetic alterations expressed by their disease, where typically third line fourth line or beyond having been killed by the best available therapies and in many cases haven't confirmed by various investigational drugs and prior hematopoietic stem cell transplants.
So let's talk about <unk> expansion trial, where we have two arms a monotherapy cohort in a combination therapy arm.
Being administered with kinetic lax, we initiated monotherapy arm of the trial earlier in the year with rapid accrual and lots of enthusiasm from investigators.
As Bill mentioned these are patients that have a great unmet medical need.
I read a rescue these patients may allow us a quicker path to registration in.
In addition, treating these patient populations will help inform our continuing development path.
We do have a regulatory end of phase one meeting scheduled with the FDA to ensure agreement on study parameters and next steps and we look forward to bringing in all of our efficacy and safety data to date.
<unk> takes our clinical development plans in a different direction, we will be sure to communicate that with you.
It is a global trial and our clinical team now has numerous sites up and running and raptor being activated across the globe.
Includes sites in the U S Korea, Australia, New Zealand and Europe .
So we expect our enrollment to accelerate even further as the year goes on.
In the aggregate expansion trial to spending to now being tested in combination with genetic box has been updated since our last call. The doublet cost and drug combination arm is up and running and dosing patients with a great amount of enthusiasm from investigators.
This study represents an attractive treatment option for patients and their physicians, leading them to enroll earlier in the course of treatment, increasing the likelihood of achieving meaningful clinical benefit.
We expect that the doublet study will support combination Registrational studies in the second line AML population.
And also will serve as a bridge to a triplet pilot study of a task then hyper method agent in frontline AML patients, which we have planned for later this year.
Also remind you that the spending has shown activity in wild type AML that is split three well type AML, which accounts for 70% of the AML population and significantly extended the market potential for this drug and this is an important differentiating feature of this debt.
We said it before but the spending safety profile with its Brad activity make it the ideal candidates for combination therapy in frontline therapy, and thats whats or ultimately working towards.
The treatment paradigm for AML is quickly shifting towards doublet and triplet combination therapies. We've highlighted to scientific article published last year in blood cancer Journal by Dr. <unk> and his team at the MD Anderson Cancer Center, which demonstrates the success, we've achieved with triplet therapy for AML, which includes hyper mapping agent in Connecticut in.
Combination with a <unk> three inhibitor. The response rates were remarkably high if this triple combination therapies are challenged by additional toxicity is carrying into the triplet <unk> kinase inhibitors and by the limitation of only treating with <unk> patients.
That's where it has been it could really standout addition anticipate hinted at in HMA.
To create a triplet that can be applied broadly to AML patients with <unk> mutated <unk> status not nearly to 30% with a <unk> mutation and can be done. So without the addition of unnecessary cardio toxicity prolonged mouse depression and those other side effects often caused by competing agents.
<unk> is also of course, a lead investigator on or after the trial enhanced remarked.
Emerging credit profile remains intact, particularly the lack of prolonged suppression in responding patients the drug could be a game changer in combination therapies.
And an independent Kols call during the first quarter actor Harry Irvette, Duke Cancer Institute expressed similar sentiments, saying, despite nib quote may be better suited for the combinations and we hope to develop and anything we have right now.
To spending with its proven breadth of activity and superior safety profile is looking like a big pharma drug that can address the most sizable markets in AML and we're developing an assertion.
Extensive potential in multiple cell populations.
As a monotherapy for accelerated approval in relapsed or refractory AML as a doublet therapy for accelerated approval in second line AML freeze.
<unk> combinations in frontline treatment naive patients and finally for use in maintenance therapy settings.
We mentioned in our last call that pharmaceutical companies have begun to take notice and that interest into spending is growing.
Continue to engagements as productive discussions indeed, we expected a global reach the required for commenced commercialization to realize the full value of.
Our team is experienced and focused on the appropriate clinical and non clinical development needed for a drug that has such extensive commercial opportunities.
In the background. We're also conducting essential support studies, we will need for an NDA. For example, we are conducting a test bed and food effect trial in human volunteers and a 13 week chronic tox study in non humans are.
Those studies have gone very well and we expect will support the types of approvals, we wish to pursue with this data.
In addition, we continue to make advancements towards manufacture commercial rate API and tablets Anda approvals.
We continue scientific exploration of our lead asset is such intended approvals.
And finally I want to mention that we believe that the kinase targeting patient response and patient safety profiles of dispassionate position it as a potential drug for the treatment of Myelodysplastic syndromes or Mds as well as a matter of fibrosis and chronic myeloid leukemia and were happy to explain that further if you have any questions about it yet.
Now, let's talk about timelines because after the it is an open label trial, we will report data when available and appropriate forums as Bill mentioned, we are planning a data update around the attainment in June but because data collection verification take time and after that it's only been open for a short while this will be an incremental update and.
As we discussed in our last call. We would expect to have a much more complete dataset, particularly for the monotherapy arm at the European School of Hematology meeting, yes age in October and even more data, including from the test and combination cohort to then be updated at ash in December .
You would expect your monotherapy response data in second half of the year to include a monotherapy registrational trial to begin in the fourth quarter of 2023 of the first quarter of 2024 <unk>.
We're also planning to rollout a frontline pilot triplet study around the end of the year.
We have a lot to look forward to in the coming months.
Our clinical team has been key in getting after the up and running so efficiently and multiple clinical psych onboard and so I want to recognize them for their execution they've done an outstanding job preparing us for the next steps, while we still have a lot ahead of us.
Like to turn the call over to our CFO looks like retained for an update on our financial status sweatshirt.
Thanks, Rob and good afternoon all.
<unk> continues to apply financial discipline throughout our operations, we continue to prioritize clinical activities to ensure we achieve milestones without sacrificing the quality of our programs as I mentioned in our last call. We've extended our cash runway into the first quarter of 2024.
Also I'd like to comment on the challenging financial.
Financial markets.
Continue to evaluate multiple approaches to finance the company while avoiding.
Minimizing some of the negative turns we've seen in some planning now.
Now, let's review the first quarter of 2022 and financials. We ended the first quarter of 2023 with approximately $35 $7 million in cash cash equivalents and investments a decrease of $11 2 million as compared to the fourth quarter of 2022.
Our increase in our burn is related to spending on the activate study.
And payments of certain accrued liabilities due in the first quarter.
During the quarter, the net loss was approximately $13 $7 million tranche.
Translating into approximately 15 <unk> per share loss.
<unk> to $11 $5 million loss for the same period in 2022.
Identified in the income statement, we had no revenues during the first quarter of 2022.
Research and development expenses were approximately $8 8 million for the quarter compared to seven $4 million during the same quarter of 2020.
Graham cost per bit.
Sputnik.
Our $4 8 million and three.
Three months ended March 31, 2020, compared to $1 2 million for the three months ended March 31 2022.
The higher program cost per test.
Current period represent the enrolment of patients in our activate study and our healthy volunteer study as well as other related expenses.
Separately program costs were approximately $1 2 million and decreased by approximately $1 5 million compared to the $2 8 million for the three months ended March 31, 2022, primarily due to lower manufacturing costs. As a result of current G III formulation, requiring less API prior formula.
<unk>, partially offset by higher clinical trial costs.
<unk> expenses were $5 $3 million for the quarter compared to $4 1 million from the same quarter of 2022.
<unk> is primarily due to professional fees and non cash stock based compensation expenses.
As of May <unk>.
2023, Actos had $93 million 653.
662 common shares outstanding during the first quarter, we issued 46427 shares from the ATM and raised net proceeds of $34000.
More information can be found in our filings on Edgar and SEDAR, let's turn it back to Dr. Rice.
Thank you Fletcher.
Now we will open the call for questions and please feel free to pose a question to any of US operator, if you could please introduce the questions.
At this time I would like to mine everyone.
If you would like to ask a question. During this time you will need to press star one wondering your telephone.
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Our first question comes from.
We're at tent off from.
Piper Sandler <unk> co. Please go ahead.
Great. Thank you very much for the update can you guys hear me okay.
Yes, Hi, Ted we can hear you.
Bill I.
I Wonder if you kind of lump it into the <unk>.
And sort of the doublet and triplet obviously than A's.
As.
Or banana clocks.
Less letting agent or standard of care.
Why go doublet first one Greg Trepp.
Is there a mechanistic rationale or Phil.
So that a little bit color. Thanks.
Right. So in just a second I'll turn it over to Dr. Bexar, but the doublet would be more directed at second line, whereas the triplet will be more directly to first line patients now let me turn it over.
Dr. Bob Yes, Bill sorry, just to add to that point I think in order for us to go into the triplet, we do need data with the doublet and I think the refractory population of the appropriate place to do that I think in practice Thats. What people are doing now with existing tyrosine kinase inhibitors. So it's not really a novel concept in that regard.
The triplet also has additional liabilities that may be more challenging more toxicity more time spent per mile suppression that may be harder to do in a relapsed refractory population compared with frontline populations. So I think.
Logically it makes sense to start with the doublet gather the data about any potential interactions or toxicity issue that we may face before going to the trip, but I think it also represents a potential viable therapy that relapse refractory population on its own.
That's super helpful. Thanks, a lot. Thank you. Thanks.
Thanks, Dave.
While mommy for our news question.
Okay.
Our next question comes from Matthew Biegler from.
Oppenheimer <unk> co. Please go ahead.
Okay, Great Hey, guys. Thanks. This is Matt Hogan on for Matt Thanks for taking our questions.
I'm curious if you could talk a bit about where you see the bar for activity in the second line setting with the condo and I guess, what do you want to see from that early combos.
And later in October .
To give you confidence that youre on the right track there. Thanks.
So Dr. Pedro why don't I turn that one to you.
Sure.
Really the pilot here with the doublet that we're doing the relapse refractory population has two purposes. One is obviously to understand the activity that that tablet will have in this patient population. So we'll be looking at that really closely. So I said I understand the safety and whether there are any concerns or discriminating features that might be favorable for just backing into the combination with <unk> as far as the bar required for.
Activity is going to depend on the patient population that we're treating different patients will have different options available to them some of them it really poor and dismal outcomes, regardless of the therapy that he is.
But if you look at the preliminary studies that have looked at other Tyson combination tyrosine kinase inhibitors in combination with <unk>, we see that the response rates are substantially better than they would be with a single tyrosine kinase inhibitor alone. So we hope to see that same pattern emerge for our drug in combination with <unk> as well.
Yeah. So Matt does that answer your question is there anything else.
That's great very exciting.
Looking forward to it okay. Thank you.
Right. Thank you.
One moment for our next question.
Our next question comes from Lee <unk> from Cantor Fitzgerald. Please go ahead.
Hey, Thanks for taking my question, maybe just a follow up on.
On the <unk>.
Presentation, maybe just frame expectations, a little bit for us.
Understanding the data set is still early but just wondering what types of data do you hope to share from the early uptake captivate trial.
Alright.
So I'll start out and then talk perhaps Dr. Bexar, Ken can add to it.
First of all we have now have completed the original dose escalation and dose exploration trial, we had put additional patients on there and so we'll be bringing all of those data together. So that we can present those at <unk>. In addition, as we have repeatedly said.
The after the trial just got rolling we have a number of patients dosed with both monotherapy as well as with doublet.
We'll have to see how much data we have at that time. It will only be a couple of months at the most a couple of months into this some of the patients. We will provide you with preliminary reads on what we do have but again it takes time for the patients to get on there to be able to evaluate at the end of cycle. One the bone marrow evaluation then confirmation at the end of cycle two.
And so on so Dr. Bexar do you want to add to that.
I want to thank you Lee for asking that question I think it is important to set expectations. We can certainly do an update on how enrollment is going give a sense of how many patients are in monotherapy in the doublet arm and so on if it does point responses take time, not only to develop but also to confirm and we don't want to get ahead of skis on that so I think that that might just be too early at the time point to really talk about.
Meaningful response rates in the activate study thus far so I wouldn't expect a lot of that of that data in great detail at that meeting. However, we do plan to do a more comprehensive study update once we get additional data.
Crude and verified and closer to that October timeframe.
Okay, maybe just.
Maybe a follow up question I think you mentioned that the safety profile for the tablet has been pretty good.
And you've seen some early flats reduction.
So I guess based on what you've seen so far does it gives you more confidence that this doublet.
It's working synergy synergy or is that still too early to tell.
Yes in order to set the response, we need to get to that bone marrow and then confirmatory bone marrow states, but youre right. You can follow the patient's peripheral circulating glass is an early metric of whether the drug is doing what you hope to be doing.
And without going into too much granular detail I'll say that we're seeing exactly what we would expect to see thus far I think et cetera.
We're happy with the progress we've seen to date as early as it happens to be.
Okay. Thank you.
And to add one thing to that it's also thus far the safety profile has been maintained so we're happy with what we're seeing even though it's very early.
Right.
Thank you Lee.
Again as a reminder, if you'd like to ask a question. Please press star one one on your telephone.
<unk> next question.
Okay.
Our next question. Our next question comes from Joseph paint paint genius from H C. Wain words. Please go ahead.
Hey, guys good afternoon.
So bill I was curious if just <unk>.
Switching to looks a little bit.
If you could discuss sort of your decision tree is going forward first for the formulation what kind of benchmarking you might have in mind I mean, without obviously getting confidential and then if you hit any of these benchmarks with regard to dosing and potential efficacy what you might be looking to do as you also look to manage cash at the <unk>.
Alright.
Thanks.
There's a lot in there.
So first of all with Lux. The one thing I will say, we will not do anything that will undermine our lead drug testbed them. So the cash the highest priority is cash going into tests, but.
But we are continuing to push forward the <unk> and it is again with that G. III formulation in terms of benchmarking.
Right now we're looking at completing sufficient number of patients to get the safety profile of the G. III at 50 milligrams, hopefully, we'll be able to get that into the near future. We will have the CSR see review the safety of that and then we would plan to dose up to a higher dose level. As we had mentioned previously the 50 milligrams of <unk>.
Three gives right about the same exposure levels as the 900 milligram. So the original formulation, which is about 18 fold difference.
And dosing as well as ultimately an equivalent amount of exposure. There. So hopefully we'll be able to demonstrate safety with 50 milligrams of G. III then move on up to the higher dose level. We haven't released yet what we expect that higher dose levels to be we could go anywhere from 50 on up to 101 to one <unk>.
Third 5200 milligrams will make a decision at that time based on the safety, we do hope to see a greater exposure level with the with the higher dosage of the G. III.
And likewise this is in AML patients, we would hope to be able to see.
Anti leukemic effect in those patients also.
Once we get that if the G. Three works as we hope then we could move it back and toward not only AML patients, we could move back towards certain b cell malignancy patients, especially certain lymphomas and we also believe we could take the G III and to certain inflammatory diseases into the future now we do not have the cash to pursue.
Sue all the inflammatory disease and the other disease states at this time, because our cash is going to spend it but that gives you.
Kind of an overview of our thought process, where we're headed reflects.
No I appreciate that and with cash in mind.
If that wasn't an issue per se.
Is this something you would envision holding on to as long as you can while youre working on task or is it something thats.
That you could see us open earlier for business development.
In many ways, it's all of those so at this point, we're keeping it.
Opened because.
We want to see how the data rollout we want to see if there are any differentiators, even in the AML patients between <unk> and <unk>.
There may be different patient populations that are affected there is the possibility in the future you might even be able to combine such agents I'm not saying, we're headed that way, but that's a possibility. So we will take a look at the data we will make a decision do we want to hang on to it again, depending on the cash or do we want to try to partnered out we already have had interest in this molecule.
But we at this point, we're focused on collecting the data engaging with potential partners and seeing if we want to go that path.
Got it thanks, Bill Alright, Thanks, Joe.
Thank you one moment for our next question.
Our next question comes from Gregory <unk> from RBC capital markets. Please go ahead.
Hi, Bill and team, it's a niche on for Greg Congrats on the progress this quarter and thanks for taking my questions. Just a couple from me on <unk>, how would you characterize the commercial opportunity for acceptance in AML and B cell malignancies, and although early which would be indications do you believe would hold the greatest probability of success.
Are there any key data points, you could point to the most efficient path forward and be up the greatest value to the growth of the company I appreciate it and thanks again.
Alright. Thanks.
As far as Lux, Yes, again, we're going to assess the effect on AML, we hope that there would be a different patient population.
Well that may be better represented than with <unk> and that way you could show the differentiation between the two but again at this point, we will do not we will not do anything to compromise the lead drug.
<unk>.
So I'm not going to speak further as to what we would do in AML, we're going to let the data drive us there, but in B cell malignancies in particular, the Follicular lymphoma <unk> sales, we've seen activity in these patients already with the original <unk> formulation. So if the <unk> G. Three new formulation continues to move forward and does well, we'd like to to be able to move.
The drug back into those into.
And to those indications.
And that could provide additional growth for the company into the future and increased our partner ability and again once.
POS we'd also like to move it into the anti inflammatory rail.
Okay.
RAF did you want to add anything to that.
Ill just add Mike as you can probably hear in Bill's voice, we remain really excited about because I remind you that decided that the great. Tina built here at after three reason I joined the company in part because of the preclinical data that <unk> had demonstrated it really is a remarkable molecule. So we just have to figure out how best to be able to give it to patients and then we want to pursue the best route for it I do agree that debt.
<unk> malignancies do seem to be a natural place for them excited to go forward and ultimately I think in combination therapy could really shine. There. So that's what we're thinking but to get to that step we really have to make sure. The formulation is doing a good job and thats, where our interests are focused now yes.
Yes, we're being very careful to temper, what we say about it we've always been excited about this molecule is Dr. Bexar said it is remarkable in its activity, we just need to find a way to get as much drug as possible.
Its activity in AML, and especially with these lymphoid malignancies okay.
Great. Thanks, so much thank you.
I am showing no further questions I will now turn the call over to Dr. Rice for closing remarks.
Alright, well I want to say, thank you to everyone for joining us. This afternoon. So 2023 already has been a year marked with a really a steady march of progress throughout the year already promised to be an exciting year ahead fructose and we look forward to keeping you updated on our progress and I also want to reinforce what Dr. Bexar said, a little bit earlier and I too want to thank our.
Clinical development team for their hard work and execution on getting this app debate trial up and running we also want to thank our investigators to patients their families and we also appreciate the support of all of you our shareholders and analysts. So thank you and have a wonderful evening.
Thank you ladies and gentlemen that concludes today's conference you may now all disconnect and have a great day.
Okay.
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