Participants
Jonathan Zung; Chief Development Officer; Curis Inc
Presentation
Operator
Good morning and welcome to Curis' fourth quarter 2024 business update call. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Diantha, please go ahead.
Thank you and welcome Curis' fourth quarter 2024 business update call. Before we begin, I would like to encourage everyone to go to the investor section of our website at www.curis.com to find our fourth quarter 2024 business update press release and related financial tables.
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.
Joining me on today's call are Jim Dentzer, President and Chief Executive Officer, and Jonathan Zung, Chief Development Officer. We 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 you, Diantha. Good morning, everyone, and welcome to Curis' fourth quarter business update call.
We made great progress this quarter in both NHL and AML. Let's start with our TakeAim lymphoma study, which is evaluating emavusertib in combination with ibrutinib in PCNSL.
Before we discuss the clinical data, I'd like to highlight the encouraging feedback we received from the EMA and FDA on the potential for conditional marketing authorization in Europe and accelerated approval in the US. As a reminder, we engaged both agencies about the potential for accelerated filings after the initial early data from PCNSL patients treated with emavusertib in combination with ibrutinib last year.
We met with the agencies in the second half of 2024 and are pleased to announce that both agencies reviewed and provided feedback on our proposed plans for the potential for an accelerated approval pathway based on our ongoing TakeAim lymphoma study. As a reminder, the study is a single-arm open label study being conducted in the US, EU, and Israel using ORR as the primary endpoint.
Both agencies agreed that patients already enrolled in the trial can be used in the submission as long as they meet the same inclusion exclusion criteria. They also provided helpful guidance on additional information such as contribution of effect to be included as part of the submission, excuse me, and initial thoughts on the design of our confirmatory study. In short, the discussions were very productive. The development timeline for emavusertib just got accelerated.
Our current Phase 1/2 study is now registrational for both the US and Europe. Obviously, this is the outcome we were hoping for. With over 30 clinical sites now open for enrollment, our goal is to complete enrollment in the next 12 to 18 months.
With that, let's turn to the clinical data. As a reminder, we're testing the emavusertib-ibrutinib combination in two distinct PCNSL populations, BTKi-naive patients, and BTKi-experienced patients.
The thesis for the emavusertib-ibrutinib combination, supported by both preclinical data and clinical data is that blocking both of the pathways driving disease in NHL, blocking the TLR pathway with emavusertib, and blocking the BCR pathway with ibrutinib maximizes down regulation of NF-κB and can enable patients to achieve an objective response even if they've been previously treated with a BTK inhibitor and progress on that treatment.
In our press release this morning, we summarized the clinical update for 27 relapsed refractory PCNSL patients in our taking lymphoma study. Including 20 BTKi-experienced patients and 7 BTKi-naive patients.
Among the 20 BTKi-experienced patients, changing tumor burden data were available for 13 of them at the cut-off date. 9 of these 13 patients demonstrated a reduction in tumor burden. Including 6 objective responses, 4 CRs and 2 PRs with 3 of the 4 CRs lasting more than 6 months.
Among the 7 BTKi-naive patients, changing tumor burden data were available for 6 of them at the cut-off date. 5 of these 6 patients demonstrated a reduction in tumor burden, including 5 objective responses, 1 CR and 4 PRs.
In summary, we're very encouraged by both the clinical data and the clarity from EMA and FDA on our proposed registrational plans. Over the next 12 to 18 months, we'll be focused on enrolling 30 to 40 additional patients to support a filing for accelerated approval. Finally, to cap off our progress in NHL this quarter. We're pleased to announce that emavusertib has been granted orphan drug designation for primary CNS lymphoma in both the US and in Europe.
With that, let's turn to AML. At the ASH conference in December, Dr. Eric Weiner from Dana-Farber presented data for 21 patients with a FLT3 mutation who had received fewer than 3 lines of prior therapy and were treated with emavusertib as monotherapy at the RP2D of 300 milligrams BID. These data show a 38% composite CR rate in the salvage line setting with 10 objective responses in 19 response valuable patients, 6 full CRs, 2 CRs with partial or incomplete hematological recovery and 2 morphologic leukemia free state responses.
We were especially encouraged to see that these responses were achieved rapidly, with 7 of 10 responses reported at the first assessment. To put these data in context, we know that FLT3 patients in the relapsed refractory setting typically receive gilteritinib, a FLT3 inhibitor which was approved with a composite CR rate of 21%.
And it's important to remember that this 21% rate was in an ideal population of patients predominantly naive to FLT3 inhibition. The emavusertib study, on the other hand, was in salvage line patients. Over 80% of the patients on emavusertib had already been treated with a FLT3 inhibitor and failed. We believe the reason emavusertib data were so compelling is its novel mechanism of action. It blocks both IRAK4 and FLT3.
For several years, it has been suggested in the literature that blocking IRAK4 can enable patients to overcome adaptive resistance to FLT3 inhibition. These clinical data clearly support that thesis.
Finally, I'd like to provide an update on our progress with the triplet study in Frontline AML. As a reminder, in 2024, we initiated a Phase 1 study of emavusertib as an add-on agent to venetoclax and azacitidine in frontline AML. This study is assessing safety and tolerability where emavusertib is added to a patient's Venaza regimen in 7, 14, and 21 day dosing regimens after they have achieved a CR on Venaza and while they remain positive for minimal residual disease.
We have successfully completed the 7-day cohort and enrollment of the 14-day cohort is currently ongoing. In short, we had a very productive 2024 and have entered 2025 with positive momentum. We look forward to providing you with additional updates as the year progresses.
With that, I'll turn the call over to Diantha for the financial update. Diantha?
Thank you, Jim.
Curis reported a net loss of $9.6 million or $1.25 per share for the fourth quarter of 2024 compared to a net loss of $117 million or $2.03 per share for the same period in 2023. Curis reported a net loss of $43.4 million or $6.88 per share for the 12 months ended December 31, 2024, compared to a net loss of $47.4 million or $8.96 per share for the same period in 2023.
Research and development expenses were $9 million for the fourth quarter of 2024 compared to $10 million for the same period in 2023. The decrease was primarily attributable to lower clinical research, consulting, and employee-related costs, partially offset by higher manufacturing costs. R&D expenses were $38.6 million for the 12 months ended December 31, 2024, compared to $39.5 million for the same period in 2023.
General and administrative expenses were $3.4 million for the fourth quarter of 2024 compared to $4.9 million for the same period in 2023. The decrease was primarily attributable to lower legal, facility, consulting, and employee-related costs. G&A expenses were $16.8 million for the 12 months ended December 31, 2024, compared to $18.6 million for the same period in 2023.
In October, we completed a registered direct offering and concurrent private placement with net proceeds of approximately 10.8 million. On March 28, 2025, we priced a registered direct offering and concurrent private placement of common stock, pre-funded warrants, and warrants with gross proceeds of approximately $10 million. The impact of these two offerings has extended our cash runway into the fourth quarter of 2025.
With that, I'd like to open the call for questions. Operator?
Question and Answer Session
Operator
(Operator Instructions)
[Pripa de Barrakunda], Truist Securities.
Hi, good morning. This is Nicole on for Pripa. Can you just talk a little bit more about cash runway and how we should be thinking about expenses going forward or any additional cost modulations we should be considering as we update our models?
Yeah. Actually, Diantha, why don't you walk through that?
Absolutely. So we've previously guided that our cash, our burn is about $10 million a quarter, and that continues to be the case. So again, these -- the proceeds from these two offerings that we did fourth quarter of last year and first quarter of this year does extend our cash runway from mid '24 to the fourth quarter of '25.
Okay, great, and one quick follow up. Can you just talk a little bit about any potential inbound interest from partners? In this environment, are there any additional hurdles for partnerships other than fitting into the landscape?
Sure. Well, as you can imagine, given the utility that we've seen so far at NHL and AML, we're on radar screens. I would say just as a matter of course, we expect that we will be continuing to have discussions on how to best move our program forward. And at some point, I suspect that's going to involve partnering with one of the major players in either the NHL or AML space. Stay tuned.
Operator
Sean McCutcheon, Raymond James.
Hey, guys. Thanks for the questions. Can you remind us how many primary central system, nervous system lymphoma patients have been given the 100-milligram VID dose of emavusertib to date, either as monotherapy or in combination with ibrutinib? And perhaps walk us through the necessary steps to meet the FDA's requirement on the individual component contributions. And you know, obviously, based on your commentary, it's a review issue for the number of patients you'll need, but would you anticipate the number at a go for dose being roughly in line with what the EMA expects? Thanks.
Yeah. Actually, Jonathan, you're probably the best to address that one.
Jonathan Zung
Sure. So, to date, we've dosed 13 patients at 100 milligrams. Those patients have been dosed in Part B of the study. And remind me of the second part of the question.
Second part was just the steps you'll need in order to meet the FDA's requirement on the individual component contributions, and then, roughly the number of patients you'd expect to need within the US at a go forward dose.
Jonathan Zung
Yeah, so we would expect that the US and Europe will be using similar data. And when we think about the dose selection, we'll be able to make that after about 9 patients that have been dosed on 100 and 200.
Operator
Li Watsek, Cantor Fitzgerald.
Yes, thank you. Good morning. Thank you so much for the update and taking our question. We were wondering if you could give us a little more color on what the EMA might expect in terms of compelling and consistent data in in terms of the response rate that you have mentioned. Thank you.
Sure. Well, why don't I start on that and then I'll ask Jonathan to opine as well.
So, I think what both agencies, clearly, I think we're so supportive of our efforts to bring a treatment to primary CNS lymphoma based on the data that we've seen to date and the data that we've seen to date are very compelling. Obviously, we would be hoping that as we complete enrollment in the study that the data remained consistent. And that the compelling results that we've seen to date hold as we finish our enrollment in that study.
And Jonathan, would you like to add your thoughts?
Jonathan Zung
Yeah, the only thing I would add is both agencies clearly acknowledged there are no approved treatments in this space, and I think that's why we had favorable discussions with them. And as Jim mentioned, where the response rate is today, as long as we are probably north of 25%, we'll or we should have positive momentum with both agencies.
Operator
(Operator Instructions)
Ed White, HC Wainwright.
Hi, thanks for taking my question. You just had mentioned the agency is looking for north of 25% ORR. Is this a bit of a change? I think in the past, you mentioned that they're looking for a CR rate above 20%.
Now, let me add to that, and then I'll ask Jonathan to opine as well.
I think what we're really looking to do is to ensure that we've got data that are consistent with the past and, of course, give us a 95% confidence interval that we can beat a null hypothesis of 10%. So 20% clearly does that, we're much higher than that now.
I think if we end up somewhere in a 25% range where we've got a lot of cushion over the 95% confidence interval, so I think really that's all we were saying that we're going at the salvage line setting in these patients simply because there really aren't good options for these patients, so that if we continue to see the kind of efficacy that we've seen to date, we should be in a in a good position.
Jonathan, do you want to add your thoughts on that?
Jonathan Zung
Yeah. Nothing to add to that, Jim.
How should we be thinking about taking leukemia, it seems like you're focusing on PCNSL patients. Should we expect to see more enrollment in the leukemia study, and also, should we expect to see more data later this year?
Yeah, so I want to be more cautious about what kind of data in leukemia that we're going to see later this year. I think the two places where everybody's excited is, of course, on the triplet study and then in potentially a monotherapy study in FLT3.
So on the triplet study, as we mentioned in the in the release and in my comments, we've completed enrollment in the 7-day cohort looks safe and well tolerated, and our goal would be, of course, to do the same for the 14 and 21-day studies. Once we've established safety, and that's the critical item in that study, make sure we can show that adding emavusertib to current standard of care is safe and tolerable.
Well then, we would move, of course, to start dosing with all three drugs starting day one, and at that point, we're looking for efficacy. We're looking to see whether adding (inaudible) does the same thing in the clinic that it did in the lab, and that is that it added efficacy to the venese or doublet. So, that would be one thing that we would look to move toward in leukemia.
And then on the other side, of course, there's a lot of interest among the KOLs for a monotherapy extension into the FLT3 population. You know, it looks as though at this point the data we have suggests emavusertib is a best-in-class FLT3 drug as a monotherapy, which makes sense, right? It's the only drug that blocks IRAK4 and FLT3, so it should be the best-in-class. We would need to run another study, a pivotal study to prove that and to gain approval, but there's a lot of enthusiasm for that path as well.
I would look forward. hopefully, as the year progresses and we make progress in getting those studies initiated, we'll have a better sense of timelines and and could be able to set for you what data we would expect when does that make sense?
Operator
And ladies and gentlemen, this concludes our question-and-answer session. I would like to turn the conference back to the company's President and CEO, James Dentzer, for any closing remarks.
Thank you, operator, and thank you, everyone, for joining us on today's call. And especially, thank you to our teammates at Curis for their hard work and for our partners, especially at Origin and the NCI and at academic sites helping us develop this important drug. We appreciate your time today and we look forward to providing updates in the near future. Operator?
Operator
Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for joining, you may now disconnect.
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