Q2 2024 Curis Inc Earnings Call
<unk> the presentation, we will conduct a question and answer session.
At any time during this call you required immediate assistance. Please press star zero for the operator. This call is being recorded on Thursday August one 2024, I would now like to turn the conference over to Dan. So the vault. Please go ahead.
Dan: Thank you and welcome to <unk> second quarter 2020 for our business update call.
Speaker Change: Before we begin I would like to encourage everyone to go to the investors section of our website at Www Dot <unk> dot com to find our second quarter 2024 business update press release and related financial tables.
Speaker Change: I would also like to remind everyone that during the call we will be making forward looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties and actual results may differ materially for additional details. Please see our SEC filings joined.
Speaker Change: Joining me on today's call are Jim Dentzer, President and Chief Executive Officer, and Jonathan Zone, Chief Development Officer will also be available for a question and answer period at the end of the call I'd now like to turn the call over to Jim. Thank.
Jim: Thank you Daniel.
Jim Dentzer: Good morning, everyone and welcome to curious with second quarter business update call.
Speaker Change: Let's start with our T game lymphoma study, which is evaluating <unk> in combination with Ibrutinib in relapsed refractory <unk> patients that have failed after treatment with a <unk> inhibitor.
Speaker Change: These patients are generally seen methotrexate chemo and radiation in the frontline setting.
Speaker Change: Followed by Ibrutinib in the second line.
Speaker Change: As patients progress on Ibrutinib, they're eligible to enroll into our study, where we add <unk> to their ibrutinib regimen.
Speaker Change: The scientific thesis for this combination.
Speaker Change: Is that blocking both of the pathways driving NHL.
Speaker Change: <unk> pathway with <unk> and the PCR pathway with Ibrutinib.
Speaker Change: Can enable patients to achieve an objective response, even after they have progressed on ibrutinib in monotherapy.
Speaker Change: We presented data for the first five patients in this study at the Ash Conference last December where we reported an objective response rate over 50%.
Speaker Change: These data were early but very encouraging, especially given the high unmet need in this population.
Speaker Change: We have continued to enroll patients in this study.
Speaker Change: And as we noted in our press release. This morning have recently initiated discussions with regulatory authorities to gain alignment on the Registrational path for <unk> in combination with Ibrutinib in primary C. NFL.
Speaker Change: It goes without saying that defining the Registrational path is a critical next step in <unk> development and I am pleased with our most recent engagement with FDA I look forward to communicating the outcome of these discussions at the appropriate time.
Speaker Change: Discussions are also progressing in Europe, where we're pleased to report that <unk> has been granted orphan drug designation for primary CNS lymphoma by the European Commission.
Speaker Change: This designation provides several benefits, including 10 years of market exclusivity.
Speaker Change: <unk> fees for protocol and scientific assistance as well as marketing authorization applications.
Speaker Change: And the central application process for marketing authorization with the European Medicines agency.
Speaker Change: While these regulatory discussions are ongoing we continue to make excellent progress on the operational front as well and expect to reach our target number of 30 clinical sites in the U S and Europe and have initial data for 15 to 20 patients by year end.
Speaker Change: Now, let's move to our taking leukemia study.
Speaker Change: Which is evaluating <unk> in monotherapy in patients with relapsed refractory AML.
Speaker Change: At <unk> earlier this year, we provided updated data for two patient populations in this study.
Speaker Change: <unk> with our splicing factor mutation and.
Speaker Change: In patients with a flip three mutation.
Speaker Change: In displacing factor mutation for a 2018 evaluable patients achieved an objective response, including one complete remission or CR.
Speaker Change: <unk> with partial hematologic recovery or CRH, and one morphologic leukemia free state or MLR FES.
In the flip three population.
Speaker Change: Six of 11 Evaluable patients achieved an objective response include.
Speaker Change: Including three Crs.
Speaker Change: One CRH.
Speaker Change: And to MLS vessels.
Speaker Change: Also of note.
Speaker Change: Three of the patients were naive to treatment.
Speaker Change: With a <unk> inhibitor all three of these patients achieved objective responses.
Speaker Change: And three of the remaining eight patients.
Speaker Change: Those who had failed prior treatment with a <unk> inhibitor.
Speaker Change: We're able to achieve an objective response with <unk>.
Speaker Change: We believe these data support <unk> novel mechanism and its potential as a treatment for patients with relapsed refractory AML.
In the frontline setting you may remember that preclinical data demonstrate a synergistic effect when <unk> is combined with Azacitidine and vanadic lacks the standard of care in frontline AML.
Speaker Change: We recently initiated a study of this triple combination that is <unk> in combination with Azacitidine and venetic box in frontline AML.
Speaker Change: We expect to have initial safety data from this study later this year.
Two responses.
And three of the remaining eight patients those who had failed prior treatment with a <unk> inhibitor.
Speaker Change: Overall, I'm very pleased with the progress and both are taking leukemia anti game lymphoma studies and I look forward to providing additional updates as the year progresses.
We're able to achieve an objective response with <unk>.
We believe these data support <unk> novel mechanism and its potential as a treatment for patients with relapsed refractory AML.
With that I'll turn the call over to Diantha for the financial update.
Diantha: Thank you Jim curious reported a net loss of $11 8 million or $2 <unk> per share as compared to a net loss of $12 million or $2 47 per share for the same period in 2023.
In the frontline setting.
May remember that preclinical data demonstrated a synergistic effect when <unk> is combined with Azacitidine and venetic lacks the standard of care in frontline AML.
Diantha: <unk> reported a net loss of $23 7 million or $4 eight per share for the six months ended June 32024, as compared to a net loss of $23 5 million or $4 87 per share for the same period in 2023 <unk>.
We recently initiated a study of this triple combination that is <unk> in combination with Azacitidine and Vanadic locks in frontline AML.
Diantha: Research and development expenses were $10 3 million for the second quarter of 2024 as compared to $10 million for the same period in 2023.
We expect to have initial safety data from this study later this year.
Overall I am very pleased with the progress and both are taking leukemia anti game lymphoma studies and I look forward to providing additional updates as the year progresses.
Diantha: Search and development expenses were $19 9 million for the six months ended June 32024, as compared to $19 2 million for the same period in 2023.
Diantha: General and administrative expenses were $4 8 million for the second quarter of 2024 as compared to $4 2 million for the same period in 2023.
Diantha: General and administrative expenses were $9 7 million for the six months ended June 32024, as compared to 9 million for the same period in 2023.
Diantha: The increases in both research and development and general and administrative expenses are primarily attributable to higher employee related costs.
Diantha: Curious as cash cash equivalents and investments totaled $28 4 million and there were approximately $5 9 million shares of common stock outstanding.
We expect that our existing cash cash equivalents and investments should enable us to maintain our planned operations into the first quarter of 2000 22025.
Diantha: With that I'd like to open the call for questions operator.
Diantha: Okay.
Speaker Change: Thank you ladies and gentlemen, we will now begin the question and answer session should you have a question. Please press the star button, followed by the number one on retouched on phone you'll hear a prompt that your hand has been raised should you wish to decline from the polling process. Please press the star button, followed by the number two.
Speaker Change: If you are using a speaker phone please lift the handset before pressing entities one moment. Please for your first question.
Speaker Change: Your first question comes from the line of Yale Jen of Laidlaw. Please go ahead.
Yale Jen: Good morning, and thanks for taking my question and congrats on the all the progress I've got two here.
Yale Jen: The first one is that in terms of the piece.
Yale Jen: Yes.
Yale Jen: Al.
Speaker Change: Readout towards the end of the year.
Speaker Change: What you consider to be the bar for advancing the program forward in other words, what will be the.
Speaker Change: Guideposts that you were looking for and then I have a follow up.
Speaker Change: Sure. So just as a reminder, youll. Thank you by the way for calling in for the question.
Speaker Change: As a reminder, we're looking to treat patients who have failed to PTK inhibitor. So let's put this into perspective. They failed first line treatment.
Speaker Change: They failed the <unk> inhibitor.
Speaker Change: If we retreated them with the <unk> inhibitor, which is really there.
Speaker Change: That seemed choice over again of course, they wouldn't respond what we're looking to see is if we can get objective responses period now I realize the data has been a lot better than that so far but I think the bar for patients is can we show that the seats that the thesis holds that even if you failed on the PTK inhibitor, adding <unk>.
Speaker Change: Do it fundamentally changes the efficacy of that regimen, that's what we're really looking for.
Speaker Change: Okay, and then of course <unk>.
Speaker Change: Larger number of patients right of course.
Speaker Change: Absolutely.
Speaker Change: You anticipate Paul maybe 15 at least 15 pages.
Paul: At this time will you report the data.
Speaker Change: Alright.
Speaker Change: Okay.
Speaker Change: Maybe the follow up question.
In terms of the leukemia.
Speaker Change: Congrats on the data.
Speaker Change: Positive data reported earlier and I believe you mentioned.
Speaker Change: Different options.
Speaker Change: Can you pursue going forward will obviously depend on the data to be reported in the near future. We'll use some of the option in terms of flow through you could have the data for the.
Speaker Change: Naive patients or.
Speaker Change: Patients.
Speaker Change: Yes.
Speaker Change: Obviously you have thanks.
The patients on that only.
Speaker Change: How would you consider different options now let the.
Speaker Change: Paul maybe you want to take that or.
Speaker Change: Sure.
Paul: Heading into 2025.
Paul: Sure.
Paul: As you know in leukemia.
Paul: More optionality and Thats.
Paul: A fortunate consequence of the design of the molecule right because the molecule hits Iraq for.
Paul: Which is expressed in nearly every patient.
Speaker Change: Ladies and gentlemen, I would like to inform you that the speaker has been disconnected T sweet oil. Thank you.
Speaker Change: Operator.
Speaker Change: Jonathan Wang from tourists generally trying to dial back in.
Jonathan Zone: We're back and Jonathan.
Speaker Change: Okay.
Speaker Change: Thank you.
Jonathan Zone: Not sure what happened what we got disconnected from the call.
Jonathan Zone: Sure.
Speaker Change: I was answering <unk> question.
Speaker Change: <unk>, perhaps you can help me with where I got cutoff.
Sure not a problem.
Speaker Change: The second question.
Speaker Change: So although leukemia, you'll have different options.
Speaker Change: So come to contemplate in terms of whether it flips III.
Peter: Peter targeting either.
Peter: <unk> premium naive or streaming experience.
Peter: Well for that.
Peter: Yes.
And that you would see obvious.
Peter: Okay.
Omar: So Omar.
Omar: So whether you want it to one to oral.
Omar: Yes.
Omar: So a couple of them.
So, let's first talk about frontline therapy, which the combination and then separately monotherapy with flip freight and then within flip three of course, breaking it out into the separate groups for naive and for experience.
Omar: Okay.
Speaker Change: As you know one of the things that makes the molecule more attractive in the leukemia setting is that it hit direct <unk> and flip three Iraq for being expressed in nearly all patients with AML and then also with three where the <unk> mutation. We know is present in roughly a third of the population.
Omar: So because it has that unique targeting.
Omar: We think it could have a mono therapy application.
Omar: In leukemia.
Omar: As opposed to frontline, where we think it will be available to all comers in combination with Azacitidine nine o'clock and of course, a non hodgkin's when it combines with that agreement.
Omar: In the flip three sub population as we look at monotherapy Youre exactly right it could be appropriate for both naive patients and experienced patients.
Omar: It would be ideal of course with infinite resources to chase after all of those populations I think one of the discussions we're going to have yet year end as we report a more full reading of the dataset.
Omar: At Ash is of course, which of these populations are we going to prioritize.
Okay.
For moving forward most aggressively so I would say stay tuned for that discussion, but all of those opportunities are in front of us.
Speaker Change: Okay, Great that's very helpful.
Omar: Thank you.
Omar: Okay, one more.
Omar: In terms of the IIT work on closing what might be to highlight.
Okay.
Speaker Change: For the upcoming one yes.
Speaker Change: Yes, I think the Iraq for symposium, we are very pleased to be doing that again this year.
Speaker Change: As you know the level of interest in Iraq.
Speaker Change: As a whole.
Speaker Change: Has gone up.
Speaker Change: In the academic community every year since we first started publishing about Iraq towards utility oncology.
Okay.
Speaker Change: We've got I think.
Speaker Change: A really great Cross section of people involved this year.
Speaker Change: Looking at leukemia experts lymphoma experts and also highlighting work in solid tumors. So the clinical data that curious it's been focusing on today and in our public forums is really in leukemia and lymphoma, because that's where our clinical data bar, but.
Speaker Change: But we've also got five Isps ongoing in solid tumors and there is a wealth of Av.
Speaker Change: Really interesting preclinical data and several of them are initiating studies now into patients as well so.
Speaker Change: Expect in the months quarters and years to come that's going to become an increasingly important and interesting part of the story.
Speaker Change: Okay great.
Speaker Change: Thats very helpful and congrats on the progress and look forward to.
Speaker Change: For more detail. Thank you very much.
Speaker Change: Okay.
Speaker Change: Thank you. Your next question comes from the line of Ed White of H C. Wainwright. Please go ahead.
Speaker Change: Okay.
Ed White: Good morning, Thanks for taking my question.
Speaker Change: Jim you mentioned year on year.
Speaker Change: Discussing kick game lymphoma.
Speaker Change: That you recently met with the FDA to discuss the Registrational path.
Speaker Change: Wanted to know your thoughts on what your ideal.
Speaker Change: Regulatory path would be.
Speaker Change: Well I think we would like to move as expeditiously as we can of course.
Speaker Change: The typical path in drug development is to conclude the phase one two study and have an end of phase meeting and then talk about with the FDA. How do you how do you design. The pivotal study I think in this case because the unmet need is so clear.
Speaker Change: Obviously, the data that we put out last December.
Speaker Change: Looked very compelling.
Speaker Change: And I think we thought it was appropriate to initiate these discussions are a little ahead of schedule.
Speaker Change: And we are grateful that the regulatory authorities were amenable to having those discussions so we're in the middle of them now.
Speaker Change: Comment on ongoing discussions, but we would look forward to working with both FDA and EMA on the most expeditious path to.
Speaker Change: This drug available to patients who are sorely needed.
Speaker Change: Okay, Jim Thanks for taking my question.
Speaker Change: You bet. Thank you.
Speaker Change: Okay.
Yeah.
Speaker Change: Operator.
Speaker Change: Thank you for that our next question comes from the line of Sumit Roy. Please go ahead.
Sumit Roy: Hi, good morning, Jim and everyone.
Speaker Change: Sorry, I was a little delayed.
Speaker Change: Just the first few minutes of your prepared remarks.
Speaker Change: Is the are you still pursuing the relapsed refractory platform flip three our spices Amin with <unk> monotherapy.
Jim Dentzer: Going forward as in PMT conversation about.
Speaker Change: Yes. So there was a similar question from Yale from Yale Jen of Laidlaw Budd.
Sumit Roy: Thank you Sumit.
Speaker Change: So as you know we've got.
Speaker Change: Opportunities in leukemia in both monotherapy and combination and of course, the combination opportunity in NHL.
Speaker Change: <unk> is probably in the foremost with People's mind, because that appears to be the one that's furthest along.
Speaker Change: As I say, we're already in discussions with regulatory authorities on what that Registrational design ought to be.
Speaker Change: <unk>.
Speaker Change: AML flipped flight fulfillment monotherapy those data look really interesting were going to have a readout.
Of that dataset of roughly 20 patients in each group by year end and then of course some.
Speaker Change: The combination, which we would expect.
Speaker Change: If it does mirror, what we saw in the lab we.
Speaker Change: We would expect this could be a really interesting added to frontline to current standard of care in that setting I think for footprint plus the soma as we see those mature data.
Speaker Change: We'll have that conversation at that time when it comes out and of course, the initial readout, even though it's safe.
Speaker Change: Safety readout.
Speaker Change: There are a lot of people interested in that as well, we're going to have a high class headache in front of ourselves.
Speaker Change: To prioritize which of these studies we focus on.
Speaker Change: First and fastest but hold that thought.
Okay. So is it fair to expect DSA FDA meetings would be held.
Speaker Change: Post ash, maybe first quarter of 'twenty five.
Speaker Change: Alright.
Speaker Change: For NHL.
Speaker Change: Since were already in process.
Our flit three we would wait to see what the data look like before we would reach out to the FDA I think in in AML. The landscape is is more crowded.
In primary CNS lymphoma, as you know there are no drugs approved.
Speaker Change: In the third line setting.
Speaker Change: I realize our data are early.
Speaker Change: But it's showing the kind of result that.
Speaker Change: There isn't a comparable result in that setting for these patients. So I think given the clear unmet need and given given the data that we've seen to date, we think theres an opportunity to get a treatment to patients that appears to be in these early days very promising so we want to move on that as aggressively as we can and as I said, we're grateful that the regulatory authorities.
Speaker Change: Agreed to pick up that discussion earlier than than we would normally do it.
Speaker Change: Got it by initially you meet them.
Speaker Change: Yes.
Yes, yes, yes.
Speaker Change: And are you seeing any specific when you are approaching the physicians.
Speaker Change: For the enrollment.
Are you seeing any specific comments like are there reluctant or there is no other options for these patients. So it's AED pitch for her to use <unk> in.
Speaker Change: This city.
Speaker Change: No.
Speaker Change: Fortunately for the patients, but Fortunately for this study I think the unmet need in this population is.
Speaker Change: <unk>.
Speaker Change: Well frankly, it's horrible for those patients.
Speaker Change: There are no drugs approved frontline as you know, it's really high dose methotrexate chemo and whole brain radiation.
Speaker Change: Once they progress on that they typically go on Ibrutinib.
Speaker Change: And then after that they are.
Speaker Change: Really nothing.
Speaker Change: We hope to be part of a solution for these patients that in bringing this new treatment it looks as though.
Speaker Change: Early days early data.
Speaker Change: But it has the potential to be very promising.
Speaker Change: And so as I say, we continue to enroll.
Speaker Change: We have a lot of enthusiasm among among that community I know when you went to the conference you were able to catch up with several of the investigators yourself.
Speaker Change: <unk> is really quite high.
Speaker Change: Early days, we know I always want to be careful to mention that.
Speaker Change: <unk>.
Speaker Change: I have to I have to say, we're very excited by what we're seeing.
Speaker Change: Our physicians are very excited.
We're glad that the regulatory authorities were interested in and entertain the discussion a little ahead of schedule, which was of course very encouraging for us.
Speaker Change: As we saw with Gilead Carte deal so MPC NSO.
Speaker Change: Fairly high icons.
Speaker Change: <unk>.
Speaker Change: Event so.
Speaker Change: Small molecule annual safety profile certainly allows it.
Speaker Change: Other question and maybe a little bit.
Question comes from the line of Sumit Roy. Please go ahead.
Speaker Change: Aside from the blood cancer in the solid tumor do we have any visibility if two bladder cancer trial, when it will start recruiting and obviously investigator.
Okay.
Hi, Good morning, Jim and everyone I'm, sorry, I was a little delayed I missed the first few minutes of your prepared remarks.
Speaker Change: <unk> trials.
Is the are you still pursuing the relapsed refractory path for flip three our spices I mean with <unk> monotherapy.
Speaker Change: With Keytruda and <unk>.
Speaker Change: Any thoughts would be appreciated.
Speaker Change: Sure. So as you know we've got.
Speaker Change: Five investigator sponsored trials going on right now in solid tumors, we have been focusing on.
Going forward is that they have the conversation about.
Yeah. So there was a similar question from Gael.
Speaker Change: The NHL study and of course, the leukemia study because those are the ones that are company sponsored and those are the ones, where we've got clinical data, but we've got studies going on in pancreatic and gastroesophageal melanoma Europe your affiliate bladder cancer and colorectal as well.
From Yale Jen of Laidlaw about that.
Thank you Sumit.
So.
No we've got.
Opportunities in leukemia in both monotherapy and combination and of course, the combination opportunity in NHL. The NHL. One is probably in the foremost of People's mind, because that appears to be the one that's furthest along.
Speaker Change: All of those studies have really nice preclinical data that have been published at various conferences over the last 12 months to 24 months and we're now at the point, where they're moving into the clinic, which is really exciting I hope we'll be in a position to see results from some of these studies in 2025.
Speaker Change: But again these are <unk> their investigator sponsored trials, they're not company sponsored so of course, we don't actually have control over either the enrollment or the reporting of data from those studies, but we're watching that with great interest and of course.
Speaker Change: In a very appreciative of the collaboration with each.
Speaker Change: These 30 sponsors.
Speaker Change: Okay.
Speaker Change: Thank you again for taking all the questions and congrats on the progress.
Speaker Change: Thank you very much.
Lee <unk>: Your next question comes from the line of Lee <unk> from Cantor. Please go ahead.
Lee <unk>: Hey, good morning, guys.
Speaker Change: Sorry, if I missed it earlier, but Jim maybe just.
Strategic question in terms of and how you view the opportunity in lymphoma.
Speaker Change: And now it sounds like the unmet need there in lymphoma is a little bit higher maybe less competitive so how you're thinking about ob prioritize.
Speaker Change: In pharma versus AML.
Speaker Change: Waiting for some maybe irregular trading quite to make a decision.
Speaker Change: Yes. Thank you Lee thanks for calling in thanks for the question. So in NHL versus AML. There are a couple of ways to answer that question.
Speaker Change: I think the interest in NHL is partially because thats. The most recent data and Thats. The one where we are in discussions of course with regulatory agencies.
Speaker Change: Across the landscape of NHL.
Speaker Change: Obviously, a much larger market as well.
Speaker Change: <unk> inhibitors in 2023 had revenue of $11 billion. It's just a it's a massive space that hasnt had any novel drugs enter into it.
I think theres, an opportunity to get a treatment to patients that appears to be in these early days very promising so we want to move on that as aggressively as we can and as I said, we're grateful that the regulatory authorities.
Agreed to pick up that discussion earlier than than we would normally do it.
Speaker Change: Excuse me in recent years and.
Speaker Change: Our our recent data.
Got it by any till you meet them.
Speaker Change: <unk>.
Yes.
Speaker Change: We of course would look to move very aggressively and primary CNS lymphoma.
Yes, yes, yes.
And are you seeing any specific when you are approaching the physicians.
Speaker Change: And then with those data in hand, and those processes underway, we would go.
<unk>.
Speaker Change: Across NHL to all of those other indications.
For the enrollment.
Are you seeing any specific comments like are there reluctant.
Speaker Change: I think that's really building the excitement from investors and why we focus on that more.
There is no other options for these patients. So it's an easy pitch for her to use <unk> in this setting.
Speaker Change: In leukemia, I think the excitement is.
Speaker Change: While it is.
No.
Fortunately for the patients, but Fortunately for this study I think the unmet need in this population is.
Speaker Change: A more competitive space as you note.
Speaker Change: The molecule really seems to be.
Speaker Change: Fortuitously designed for an AML setting.
<unk>.
Speaker Change: Obviously deliberately designed as <unk> four inhibitor and as you know we deliberately designed key oncology targets of interest, but because it hits Iraq point set three it really has the ability to offer.
Speaker Change: Unusual benefit.
Speaker Change: A unique and independent targeted benefit for patients in that setting.
Speaker Change: So, yes, I think the.
Speaker Change: Excitement on NHL. It is partially because of the advance data the data within the context of the unmet need and the regulatory progress, but AML also very certainly very high on our radar screen.
Speaker Change: Yes, I appreciate the color.
Speaker Change: And then maybe a question on the frontline AML combo strategy just curious.
Speaker Change: If there is a plan to maybe quantify by ice.
Speaker Change: For long question and May be Havent, Scott deals around that as well as for our partners.
Speaker Change: Yeah. So thank you.
Speaker Change: I think we're thinking in leukemia as you know.
Speaker Change: Certainly as you're implying that there is a separate strategy for monotherapy.
Speaker Change: Versus combination.
Speaker Change: So.
Speaker Change: We which slipped three is an additional target.
Speaker Change: I think that offers the ability given that the drug targets, both <unk> and <unk> offers the potential for best in class therapy, among the <unk> inhibitors, which is a third of the population in AML and again I know you know this but for the benefit of others on the call.
Speaker Change: The research that we're pointing to originally published with Noga or paper showed that the reason why patients on a flip <unk> inhibitor don't do better than you might expect on a <unk> three inhibitor is the escape path as Iraq War.
Speaker Change: Because those are the ones that are company sponsored and those are the ones, where we've got clinical data, but we've got studies going on in pancreatic and gastroesophageal melanoma Europe your affiliate bladder cancer and colorectal as well.
Speaker Change: Specifically toll like receptor signaling through Iraq floor, so by blocking both <unk> and direct for we're blocking both the primary driver our primary path.
Speaker Change: <unk> and its escape.
Speaker Change: And that really in our view, even though the data are early it explains why the data look to be better.
All of those studies have really nice preclinical data.
Speaker Change: And then other <unk> efforts. So monotherapy there I think is a really exciting alternatives.
That had been published at various conferences over the last 12 months to 24 months and we're now at the point, where they're moving into the clinic, which is really exciting I hope we'll be in a position to see results from some of these studies in 2025.
Speaker Change: In frontline.
Speaker Change: Just started that study so we need to see whether or not it will pan out, but the preclinical data are clearer Iraq for.
Speaker Change: As expressed in nearly every patient with AML in all corners.
Speaker Change: And we know <unk> adenine in genetic clock, which is the current standard of care don't hit it.
Speaker Change: So the preclinical data showed that when you added.
Speaker Change: <unk> asserted to standards of care when you added <unk>.
Speaker Change: Two the <unk> doublet.
Speaker Change: There was a.
Speaker Change: Significant increase in efficacy.
Speaker Change: We hope to see that in patients and we've just started that study but stay tuned.
Speaker Change: I hope that helps.
Speaker Change: Yes.
Speaker Change: Once again, ladies and gentlemen should you have a question. Please press the start button followed by the number one on your touch on phone and then you will hear prompts that your hand has been race.
Speaker Change: There are no further questions at this time I would now like to turn the call back over to Jim.
Speaker Change: Please go ahead.
Jim Dentzer: Thank you operator, and thank you everyone for joining today's call.
Jim Dentzer: And as always thank you to the patients and families participating in our clinical trials.
Speaker Change: So our team at <unk>.
Speaker Change: For their hard work and commitment and to our partners at origin, the NCI and the academic community.
Speaker Change: Are there ongoing collaborations supports.
Speaker Change: We look forward to updating you against up.
Speaker Change: Operator.
Speaker Change: Ladies and gentlemen, this concludes your conference call for today, we thank you for participating in assets you. Please disconnect your lines.
Speaker Change: That hasn't had any novel drugs enter into it.
Excuse me in recent years.
Yes.
Our recent data.
<unk>.
Speaker Change: We of course would look to move very aggressively and primary CNS lymphoma.
Speaker Change: And then with those data in hand, and those processes underway, we would go.
Cross NHL to all of those other indications.
I think that's really building the excitement from investors and why we focus on that more.
In leukemia, I think the excitement is.
While it is.
Speaker Change: A more competitive space as you note.
Speaker Change: The molecule really seems to be.
Speaker Change: Fortuitously designed for an AML setting.
Speaker Change: Potential for best in class therapy, among the flip three inhibitors, which is a third of the population in AML and again I know you know this but for the benefit of others on the call.
Speaker Change: The research that we're pointing to originally published with Melgaard paper showed that the reason why patients on a flip three inhibitor don't do better than you might expect on a <unk> three inhibitor is the scape path as Iraq War.
Speaker Change: Specifically toll like receptor signaling through Iraq for so by blocking both <unk> and direct for we're blocking both the primary driver primary path of the disease and its escape.
Speaker Change: That really in our view, even though the data are early it explains why the data look to be better.
Speaker Change: And then other <unk> III efforts some monotherapy there I think is a really exciting alternatives.