Good afternoon. My name is Antoine Alexander. I will be your conference operator today. I would like to welcome everyone to the Aptose Biosciences reports results for the first quarter ended March 31, 2023. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a Q&A session. To ask a question during this session, you will need to press star one one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to introduce Ms. Susan Pietropaolo. Please go ahead.
Thank you, Antoine. Good afternoon, welcome to the Aptose Biosciences conference call to discuss financial and operational results for the first quarter ended March 31, 2023. Earlier today, Aptose issued a press release relating to these financial results. The news release, as well as related SEC filings, are accessible on Aptose's 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. and Canadian securities laws. Forward-looking statements reflect Aptose's current expectations regarding future events. They are not guarantees of performance, 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 Aptose's most recent annual report on Form 10-K and SEC 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 call, 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 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, today we will provide you with an incremental but important update. We also are planning a corporate update around the European Hematology Association, or EHA, conference in June, where we plan to provide additional data.
Before I get into the findings with our pipeline, I'll remind you again that we continue to tighten our belts to most efficiently invest our current cash into the 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 today's financings.
We continue to pursue partnering activities that can provide strategic support to our programs. We expect to say more about these topics in the coming days. Now let's hit the headlines for today. First, the dose escalation and dose exploration trial with tuspetinib has been completed, and tuspetinib delivered clinical responses as a monotherapy over four dose levels in very difficult to treat populations of patients with relapsed or refractory AML.
Second, dosing of the combination of tuspetinib and venetoclax, referred to as the TASP-VEN doublet, is underway for relapsed or refractory AML patients in our APTIVATE expansion trial. Third, we already are seeing brisk enrollment of the tuspetinib monotherapy arm and of the TASP-VEN doublet arm in the APTIVATE expansion trial, and we already have seen early signs of clinical activity.
Fourth, the superior safety profile of tuspetinib continues to be observed, including a reduced risk of myelosuppression with prolonged dosing. Fifth, continuous dosing with the luxeptinib, yes, luxeptinib, with the G3 formulation is ongoing. Finally, I'll remind you that we have our annual shareholders meeting planned for May 23rd in just a few weeks. Having delivered the headlines, now I want to provide a few details relating to our lead agent, tuspetinib. This oral small molecule kinase inhibitor was licensed from Hanmi Pharmaceutical in South Korea. We took over the development reins for tuspetinib 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 that continues to deliver clinical findings that inspire us to view tuspetinib as a potentially playing several key roles in the future treatment regimens of patients with AML and potentially other hematologic malignancies. We continue to be emboldened by what we're seeing with every emerging piece of data. By targeting all forms of FLT3, the SYK kinase, JAK1 and JAK2, RSK 1 and 2, and the mutant forms, but not the wild type form of KIT, tuspetinib 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 phase I/II trial with tuspetinib, where we observed responses across four dose levels and across a broad range of very ill and difficult to treat AML patients that had been failed by other therapies. Plus, tuspetinib was remarkably well tolerated. As a follow on to the dose escalation and dose exploration trial, we initiated the APTIVATE phase I/II expansion trial during the first quarter of this year. In the APTIVATE trial, relapsed refractory AML patients are being treated with tuspetinib as a monotherapy or with tuspetinib and venetoclax as a doublet therapy.
With the monotherapy arm, the APTIVATE expansion trial is designed to confirm monotherapy activity through patient enrichment of certain mutationally defined AML populations, including TP53 mutant patients, FLT3 mutant patients who have been failed by a prior FLT3 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 tuspetinib.
A successful monotherapy arm may provide options for accelerated approval of tuspetinib in relapsed or refractory AML. While it's too early to glean formal response data from the first set of patients treated with tuspetinib monotherapy on the APTIVATE trial, I can say that we already have begun to see clear anti-leukemic activity. With the combination arm, the APTIVATE expansion trial is designed to evaluate tuspetinib in combination with venetoclax.
Several weeks ago, we told you that sites had begun patient enrollment on the TUS/VEN combination. I'm really pleased to announce today that the rate of accrual in this trial has been far more brisk than expected. There's tremendous enthusiasm from investigators, and since our last call, we have dosed a number of patients in the TUS/VEN doublet combination cohort.
Hereto, it's too early to draw any firm response conclusions, but thus far during the early weeks of dosing, the TUS/VEN 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 tuspetinib to date. I'm happy to confirm that during the most recent safety review held at the end of the first quarter, that unique safety profile of tuspetinib continues with no concerning trends.
The importance of a good safety profile cannot be underestimated, as we get questioned all the time, especially because several other AML drugs approved or in development may be limited by toxicities caused by the need for high plasma exposure levels and the excessive suppression of a single target required to elicit responses.
For example, published reports show that certain FLT3 inhibitors, such as gilteritinib, to achieve clinical responses require plasma exposure levels that cause near complete inhibition of the FLT3 target in AML cells, as measured by a classic plasma inhibitory activity or PIA assay on reporter cells. Unfortunately, plasma levels of such a drug that requires complete inhibition of the target would also be expected to cause excessive inhibition of the same target in normal cells and lead to toxicities, and that's exactly what's observed clinically.
In contrast, tuspetinib employs a different strategy to simultaneously suppress a handful of oncogenic kinases that drive pathways critical for leukemogenesis. Using the same classic PIA assay, we see that the plasma from patients treated with tuspetinib can deliver near complete inhibition of FLT3 and STAT5. However, in patients who achieve clinical responses with tuspetinib, complete inhibition of a single target is not required.
Rather, clinical responses with tuspetinib can be achieved with 50% to 80% inhibition of FLT3 and the downstream STAT5 signaling. The difference is that tuspetinib can induce clinical responses by incrementally suppressing several oncogenic pathways simultaneously, rather than requiring complete inhibition of any one target. Consequently, tuspetinib appears to achieve clinical responses at lower exposures, thereby avoiding many of the toxicities observed with competing agents. It's this favorable safety pattern that differentiates tuspetinib from its competitors.
I'll also remind you that tuspetinib has shown activity in wild type AML, which accounts for 70% of the AML population, thereby significantly extending the market potential for this drug. This too is a key differentiating feature of tuspetinib. We've said it before, but tuspetinib's safety profile with its broad activity makes it the ideal candidate for combination therapy and frontline therapy, and that is where we're ultimately moving towards.
Dr. Bejar will speak more about our plans for tuspetinib in combination therapy in the treatment of AML in just a moment. Now just a quick mention of luxeptinib, our secondary pipeline program. You're aware that our G3 formulation of luxeptinib is being administered to AML patients at the 50 mg dose level, which is roughly equivalent to the 900-milligram dose level of the original G1 formulation.
We continue to collect PK and safety data. Our plan is to escalate dosing to determine if G3 can deliver greater plasma levels. Pre-clinically, luxeptinib is an extraordinary molecule. We're giving the G3 formulation every chance to succeed. Finally, I'll mention our planned upcoming milestones as we march toward key catalysts for the year. Our end of phase I meeting with the U.S. FDA is scheduled during the second quarter of this year. The meeting is designed to ensure that we're in agreement on tuspetinib clinical study parameters and next steps in the development of the tuspetinib program.
Around the time of the EHA Congress in June, we plan to present clinical findings to include tuspetinib dose escalation and dose exploration findings in relapsed or refractory AML patients and our preliminary findings in patients dosed with monotherapy tuspetinib and the TUS/VEN doublet in the APTIVATE trial. Around the European School of Haematology or ESH meeting in October, we plan to present maturing tuspetinib clinical data set.
Around the 65th Annual Society of Hematology or ASH Annual Meeting and exposition in December, we plan to present an even more robust and more mature clinical data set with tuspetinib. During the fourth quarter of this year, we plan to discuss strategies for potential future monotherapy accelerated development of tuspetinib for doublet phase II development of TUS/VEN, and for a pilot triplet development with TUS/VEN and a hypomethylating agent. Let me now hand it over to Dr. Rafael Bejar, our Chief Medical Officer, to go into more detail about the ACTIVATE clinical trial with tuspetinib and AML and to go over the clinical plans and timelines with you. Raf?
Thanks, Bill. First, it's important to remind you that in dose escalation and exploration phase of our trial, TUS was able to achieve complete remissions in a very ill relapsed or refractory AML patient population while also being safe and well-tolerated. We can't drive home enough that these are incredibly difficult patients to treat with highly adverse genetic and epigenetic alterations expressed by their disease.
We're typically third line, fourth line or beyond, having been failed by the best available approved therapies and in many cases having been failed by various investigational drugs and prior hematopoietic stem cell transplants. Let's talk about APTIVATE expansion trial, where we have two arms, a monotherapy cohort and a combination therapy arm, tuspetinib being administered with venetoclax. We initiated the 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, the ability to rescue these patients may allow us a quicker path to registration. In addition, treating these patient populations will help inform our continued development path. We do have a regulatory end of phase I meeting scheduled with the FDA to ensure agreement on study parameters and next steps, we look forward to bringing them all of our efficacy and safety data to date.
If that discussion takes our clinical development plans in a different direction, we will be sure to communicate that with you. This is a global trial, our clinical team now has numerous sites up and running en route to being activated across the globe. This includes sites in the U.S., Korea, Australia, New Zealand and Europe.
We expect our enrollment to accelerate even further as the year goes on. In the APTIVATE expansion trial, tuspetinib is now being tested in combination with venetoclax. As Bill updated you since our last call, the doublet TUS/VEN 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 and increasing the likelihood of achieving a meaningful clinical benefit. We expect that the doublet study will support combination registrational studies in the second-line AML population. Also will serve as a bridge to a triplet pilot study of a TUS/VEN hypomethylating agent in front-line AML patients, which we have planned for later this year.
I'll also remind you that tuspetinib has shown activity in wild type AML, that is FLT3 wild type AML, which accounts for 70% of the AML population and significantly extends the market potential for this drug. This is an important differentiating feature of tuspetinib. We've said it before, but tuspetinib's safety profile with its broad activity make it the ideal candidate for combination therapy and front-line therapy, and that's what we're ultimately working towards.
The treatment paradigm for AML is quickly shifting towards doublet and triplet combination therapies. We've highlighted a scientific article published last year in Blood Cancer Journal by Dr. Naval Daver and his team at the MD Anderson Cancer Center. This demonstrates the success they've achieved with triplet therapy for AML, which includes hypomethylating agent and venetoclax in combination with the FLT3 inhibitor. The response rates were remarkably high.
Those triplet combination therapies are challenged by additional toxicities carried into the triplet by the tyrosine kinase inhibitors and by the limitation of only treating FLT3-mutated patients. That's where tuspetinib could really stand out. Addition of tuspetinib to the VEN HMA doublet is envisioned to create a triplet that can be applied broadly to AML patients with FLT3 mutated or unmutated status, not merely the 30% with a FLT3 mutation, and can be done so without the addition of unnecessary cardiotoxicity, prolonged myelosuppression, and those other side effects often caused by competing agents.
Dr. Daver is also, of course, the lead investigator on our APTIVATE trial, and he has remarked that if tuspetinib's emerging profile remains intact, particularly the lack of prolonged myelosuppression in responding patients, the drug could be a game changer in combination therapies. In an independent KOL call during the first quarter, Dr. Harry Erba of Duke Cancer Institute expressed similar sentiments, saying tuspetinib "may be better suited for the combinations that we hope to develop than anything we have right now." Tuspetinib, 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 it as such.
It has extensive potential in multiple subpopulations as a monotherapy for accelerated approval in relapsed or refractory AML, as a doublet therapy for accelerated approval in second-line AML, for use in triplet combinations in front-line treatment-naïve 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 in tuspetinib is growing. We continue to engage in these productive discussions.
Indeed, we expect that a global reach will be required for commercialization to realize the full value of tuspetinib. 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 tuspetinib food effect trial in human volunteers and a thirteen-week chronic tox study in non-humans. Those studies have gone very well and we expect will support the types of approvals we wish to pursue with tuspetinib. In addition, we continue to make advancements towards the manufacture of commercial-grade API and tablets for NDA approvals. Likewise, we continue scientific exploration of our lead assets to support such intended approvals.
Finally, I want to mention that we believe the time the kinase targeting patient response and patient safety profiles of tuspetinib position it as a potential drug for the treatment of myelodysplastic syndromes, or MDS, as well as myelofibrosis and chronic myelomonocytic leukemia. We're happy to explain that further if you have any questions about it at the end. Now let's talk about timelines. Because APTIVATE is an open label trial, we will report data when available at appropriate forums. As Bill mentioned, we are planning a data update around the EHA meeting in June, but because data collection verification take time and APTIVATE has only been open for a short while, this will be an incremental update.
As we discussed in our last call, we would expect to have a much more complete data set, particularly for the monotherapy arm at the European School of Haematology Meeting, ESH, in October, and even more data including from the tuspetinib combination cohort to be updated at ASH in December. We would expect our monotherapy response data in second half of the year to include a monotherapy registrational trial to begin in fourth quarter of 2023 or the first quarter of 2024.
We're also planning to roll out 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 APTIVATE up and running so efficiently and multiple clinical sites on board. 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. I'd like to turn the call over to our CFO, Fletcher Payne, for an update on our financial status. Fletcher?
Thanks, Raf. Good afternoon all. Aptose continues to apply financial discipline throughout our operations. We continue to prioritize clinical activities, 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. I'd like to comment on the challenging financial markets. We continue to evaluate multiple approaches to finance the company while avoiding and minimizing some of the negative terms we've seen in some financings. Let's review the first quarter of 2023 financials. We ended the first quarter of 2023 with approximately $35.7 million in 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 APTIVATE study and payments of certain accrued liabilities due in the first quarter. During the quarter, the net loss was approximately $13.7 million, translating into approximately $0.15 per share loss, compared to $11.5 million loss for the same period in 2022. As 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 $7.4 million during the same quarter of 2022. Program costs for the tuspetinib were $4.8 million and for the three months ended March 31, 2023, compared to $1.2 million for the three months ended March 31st, 2022.
The higher program costs for tuspetinib in the current period represent the enrollment of patients in our APTIVATE study and our health of volunteer site as well as other related expenses. Luxeptinib 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 the result of current G3 formulation requiring less API than the prior formulation, partially offset by higher clinical trial costs.
G&A expenses were $5.3 million for the quarter, compared to $4.1 million from the same quarter of 2022. The increase is primarily due to professional fees and non-cash stock-based compensation expenses. As of May 8, 2023, Aptose had 93,653,662 common shares outstanding. During the first quarter, we issued 46,427 shares from the ATM and raised net proceeds of $34,000. 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'll open the call for questions. 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 remind everyone, if you would like to ask a question during this time, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. If you would like to withdraw your question, please press star one one again. Please stand by while I compile the Q&A roster. Our first question comes from Edward Tenthoff from Piper Sandler & Co. Please go ahead.
Great. Thank you very much for the update. Can you guys hear me okay?
Yes. Hi, Ed . We can hear you.
Hey, how are you, Bill?
How are you?
I wanted to get a little bit into the mechanism and sort of the doublet and the triplet. Obviously, venetoclax is, or, you know, venetoclax and a hypomethylating agent are standard of care. You know, why go doublet first and why not straight to the triplet? Is there a mechanistic rationale or just wanna understand that a little bit better? Thanks.
All right. In just a second, I'll turn it over to Dr. Bejar. The doublet would be more directed at second line, whereas the triplet would be more directly to first line patients. Let me turn it over.
That makes sense. Sorry.
Dr. Bejar.
Bill, 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 is the appropriate place to do that. I think in practice, that's 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 amount of suppression. That may be harder to do in a relapsed refractory population compared to a front-line population. I think logically it makes sense to start with the doublet, gather the data about any potential interactions or toxicity issues that we might face before going to the triplet. I think it also represents a potential viable therapy for the relapsed refractory population on its own.
That's super helpful. Makes a lot of sense. Thank you.
Oh, thanks, Ed.
One moment for our next question. Our next question comes from Matthew Biegler from Oppenheimer & Co. Please go ahead.
Okay, great. Hey, guys. Thanks. This is Matt Hagen on for Matt. Thanks for taking our questions. I was curious if you could talk a bit about where you see the bar for activity in the second line setting with the combo. I guess, you know, what do you wanna see from that early combo data at EHA and later in October, to give you confidence that you're on the right track there? Thanks.
Yeah. Dr. Bejar, why don't I turn that one to you?
Sure. Really the pilot here with the doublet that we're doing in the relapsed refractory population has two purposes. One is obviously to understand the activity that that doublet will have in this patient population. We'll be looking at that really closely. It's also to understand the safety and whether there are any concerns or discriminating features that might be favorable for tuspetinib in the combination with venetoclax.
As far as the bar required for activity, it's gonna depend on the patient population that we're treating. Different patients will have different options available to them. Some of them with really poor and dismal outcomes, regardless of the therapy that's used. If we look at the preliminary studies that have looked at other tyrosine combination, tyrosine kinase inhibitors in combination with venetoclax, we see that the response rates are substantially better than they would be with a single tyrosine kinase inhibitor alone. We hope to see that same pattern emerge for our drug combination with venetoclax as well.
Yeah. Matt, does that answer your question? Is there anything else?
It does. No, that's great. Very exciting. Yeah, I was looking forward to it.
Okay. Thank you.
All right. Thank you. One moment for our next question. Our next question comes from Li Watsek from Cantor Fitzgerald. Please go ahead.
Hey, thanks for taking the questions. Maybe just a follow-up on the EHA presentation. Maybe just frame the expectations a little bit for us, understanding the data set is still early, but just wondering, you know, what types of data do you hope to share from the APTIVATE trial?
All right. Hi, Li. I'll start out and then perhaps Dr. Bejar can add to it. First of all, we now have completed the original dose escalation and dose exploration trial. We had put additional patients on there, we'll be bringing all those data together so that we can present those at EHA. In addition, as we have repeatedly said, the APTIVATE 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. There'll only be a couple of months at the most into this. Some of the patients. We'll provide you with preliminary reads on what we do have. Again, it takes time for the patients to get on there, to be able to evaluate it in the cycle 1, the bone marrow evaluation, then confirmation at the end of cycle two and so on. Dr. Bejar, do you wanna add to that?
No, I wanna thank you, Li, 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 and in the doublet arm and so on. To Bill's point, responses take time not only to develop but also to confirm, and we don't want to get ahead of our skis on that. I think that might just be too early of a time point to really talk about meaningful response rates in the APTIVATE study thus far. Wouldn't expect a lot 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 accrued and verified closer to that October timeframe.
Okay. Maybe just, maybe a follow-up question. I think you mentioned that, you know, the safety profile for the doublet has been pretty good and you've seen some early blast reductions. I guess based on what you've seen so far, does it give you more confidence that this doublet, you know, it's working, has synergy or is it still too early to tell?
In order to assess the response, we need to get to that bone marrow and then confirmatory bone marrow stage. You're right, you can follow the patient's peripheral circulating blast as an early metric of whether the drug is doing what you hope to be doing. 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 it's, we're happy with the progress we've seen to date as early as it happens to be.
Yeah.
Okay. Thank you.
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.
All right. Thank you, Li. As a reminder, if you would like to ask a question, please press star one one on your telephone. One moment for our next question. Our next question comes from Joseph Pantginis from H.C. Wainwright. Please go ahead.
Hey, guys. Good afternoon. Bill, I was curious if, you know, just switching to LUX a little bit, if you could discuss sort of your decision trees going forward. You know, first for the formulation, what kind of benchmarking you might have in mind, I mean, without obviously getting confidential. You know, if you hit any of these benchmarks with regard to dosing and potential efficacy, you know, what you might be looking to do as you also look to manage cash at the company.
All right. Thanks. There's a lot in there. First of all, with LUX, the one thing I will say, we will not do anything that will undermine our lead drug, tuspetinib. The cash, the highest priority is cash going into tuspetinib. But we are continuing to push forward the luxeptinib. It is again with that G3 formulation. In terms of benchmarking, right now we're looking at completing sufficient number of patients to get the safety profile of the G3 at 50 mg. Hopefully we'll be able to get that into the near future. We'll have the CSRC 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 mg of the G3 gives right about the same exposure levels as the 900 mg of the original formulation, which is about an 18-fold difference in dosing as well as ultimately an equivalent amount of exposure there. Hopefully we'll be able to demonstrate safety with the 50 mg of G3, then move on up to a higher dose level. We haven't released yet what we expect that higher dose level to be. We could go anywhere from 50 mg on up to 100 mg, one to 150 mg, 200 mg. We'll make a decision at that time based on the safety. We do hope to see a greater exposure level with the higher dosage of the G3.
Likewise, this is in AML patients. We'd hope to be able to see an anti-leukemic effect in those patients also. Once we get that, if the G3 works as we hope, then we could move it back in toward not only AML patients, we could move it back towards certain B-cell malignancy patients, especially certain lymphomas. We also believe we could take the G3 then into certain inflammatory diseases into the future. Now, we do not have the cash to pursue all the inflammatory diseases and the other disease states at this time, because our cash is going into tuspetinib. That gives you a kind of an overview of our thought process where we're headed with LUX.
No, I appreciate that. 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 you're working on TUSP, or is this something that's, that you could see as open earlier for business development?
In many ways, it's all of those. At this point, we're keeping it very open because we want to see how the data roll out. We want to see if there are any differentiators, even in the AML patients between luxeptinib and tuspetinib. 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.
We'll take a look at the data. We'll make a decision, do we want to hang on to it? Again, depending on the cash, or do we want to try to partner it out? We already have had interest in this molecule. We at this point, we're focused on collecting the data, engaging with potential partners and seeing if we wanna go that path.
Got it. Thanks, Bill.
All right. Thanks, Joe.
Thank you. One moment for our next question. Our next question comes from Gregory Renza from RBC Capital Markets. Please go ahead.
Hi, Bill and team. It's Anish on for Greg. Congrats on the progress this quarter, and thanks for taking my questions. Just a couple from me on LUX. How would you characterize the commercial opportunity for luxeptinib in AML and B-cell malignancies? Although early, which of the indications do you believe would hold the greatest probability of success? If there are any key data points you could point to, the most efficient path forward and be of the greatest value to the growth of the company? Appreciate it, thanks again.
All right. Thanks. As far as LUX, yes. Again, we're gonna assess the effect on AML. We hope that there would be a different patient population in AML that may be better represented than with tuspetinib, and that way you could show the differentiation between the two. Again, at this point, we will not do anything to compromise the lead drug, tuspetinib. I'm not gonna speak further as to what we would do in AML. We're gonna let the data drive us there. In B-cell malignancies, in particular the follicular lymphoma, DLBCLs, we've seen activity in these patients already with the original G1 formulation.
If the G1 G3 new formulation continues to move forward and does well, we'd like to be able to move the drug back into those indications, and that could provide additional growth for the company into the future and increase the partner ability. Again, once, if possible, we'd also like to move it into the anti-inflammatory realm. Okay. Raf, did you want to add anything to that, Dr. Bejar?
No, I'd just add, like, as you can probably hear in Bill's voice, we remain really excited about luxeptinib. I remind you that besides the great team that Bill here at Aptose, the reason I joined the company in part was because of the preclinical data that luxeptinib 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 wanna pursue the best route forward.
I do agree that lymphoid malignancies do seem to be a natural place for luxeptinib to go forward. Ultimately, I think in combination therapy could really shine there. That's what we're thinking. To get to that step, we really have to make sure the formulation is doing a good job, and that's where our interests are focused now.
Yeah. We're being very careful to temper what we say about it. We've always been excited about this molecule, as Dr. Bejar said. It is remarkable in its activity. We just need to find a way to get as much drug in as possible, define 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.
Well, I wanna say thank you to everyone for joining us this afternoon. 2023 already has been a year marked with a really a steady march of progress throughout the year already. Promises to be an exciting year ahead for Aptose, we look forward to keeping you updated on our progress. I also want to reinforce what Dr. Bejar said a little bit earlier. I too wanna thank our clinical development team for their hard work and execution on getting this APTIVATE trial up and running. We also wanna thank our investigators, the patients, their families, and we also appreciate the support of all of you, our shareholders and analysts. 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.