Q4 2024 Curis Inc Earnings Call
Speaker Change: Good morning and welcome to Curis's fourth quarter, 2024 Business Update Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference of specialists by pressing star key, I'll advise zero. After the company's prepared remarks, all participants will have an opportunity to ask questions.
Speaker Change: To ask a question, you may press a star then the number one on your touchstone phone. To withdraw your question, please press a star then the number two. Please note this event is being recorded. I would now like to turn the conference over to Diantha Duvall, the Chief Financial Officer, Diantha, please go ahead.
Speaker Change: to find our fourth 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.
Speaker Change: Joining me on today's call are Jim Dentzer, President and Chief Executive Officer and Jonathan Zohm, Chief Development Officer. We will also be available for a question and answers period at the end of the call. I'd now like to turn the call over to Jim.
Jim Dentzer: Thank you, Diantha. Good morning, everyone, and welcome to Curis' fourth quarter business update call.
Speaker Change: We make great progress this quarter, in both NHL and ANL.
Speaker Change: Let's start with our Take Game lymphoma study, which is evaluating M of Usertib in combination with Ibrutinib in PCNSL.
Speaker Change: 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.
Speaker Change: As a reminder, we engaged both agencies about the potential for accelerated filings after the initial early data from PCNSL patients treated with M.O. Vossertib in combination with Ibrutinib last year.
Speaker Change: We met with the agencies in the second half of 2024.
Speaker Change: 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 Take
Speaker Change: 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.
Speaker Change: 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.
and initial thoughts on the design of our confirmatory study.
Speaker Change: In short, the discussions were very productive. The development timeline for M.O. Research had just got accelerated.
Speaker Change: Our current Phase 1-2 study is now registration for both the U.S. and Europe .
Speaker Change: 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.
Speaker Change: As a reminder, we are testing the Emma Hussertib Ibrutinib combination in two distinct PCNSL populations.
BGKI Naive Patients
and BTKI experienced patients.
The Deceses
for the Emma Hussertive Abrutinib Combination.
supported by both pre-clinical data and clinical data.
Speaker Change: is that blocking both of the pathways driving disease in NHL.
Blocking the TLR pathway with Emma Bussertit [inaudible]
Speaker Change: and blocking the BCR pathway with Ibrutnant maximizes down-regulation of NF-Kappa B and can enable patients to achieve an objective response, even if they've been previously treated with a BTK inhibitor and progressed on that treatment.
Speaker Change: In our press release this morning, we summarized the clinical update for 27 relapsed refractory PCNSL patients in our tick-aim lymphoma study.
including 20 BTKI experienced patients.
and seven BTKI naive patients.
Speaker Change: Among the 20 BTTI experienced patients, changing tumor burden data were available for 13 of them at the cutoff date.
Speaker Change: 9 of these 13 patients demonstrated a reduction in tumor burden.
including six objective responses, four CRs and two PRs.
Speaker Change: with three of the four CRs lasting more than six months.
among the seven BTKI naive patients.
Speaker Change: Changing tumor burden data were available for six of them at the cut-off date.
Speaker Change: Five of these six patients demonstrated a reduction in tumor burden, including five objective responses, one CR and four PRs.
Speaker Change: In summary, we're very encouraged by both the clinical data and the clarity from EMA and FDA on our proposed registration of plans.
Speaker Change: 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.
Speaker Change: We're pleased to announce that Emma Vussertive has been granted orphan drug designation for primary CNS lymphoma in both the US and in Europe .
With that, let's turn to AML.
Speaker Change: At the Ash Conference in December , Dr. Eric Weiner from Dana Farber presented data for 21 patients with a flip-3 mutation who had received fewer than three lines of prior therapy and were treated with M.O.V. assertive as monotherapy at the RP2D of 300 mg B.I.D.
Speaker Change: These data show a 38% composite CR rate in the salvage line setting.
Speaker Change: with ten objective responses in 19 responsive valuable patients. Six full CRs
Two CRs with partial or incomplete hematological recovery.
and two morphologic leukemia-free state responses.
Speaker Change: We were especially encouraged to see that these responses were achieved rapidly, with seven of ten responses reported at the first assessment.
to put these data in context.
We know that click three patients in the relapsed refractory setting.
Tickley received guilt or written it.
Speaker Change: A Flip 3 inhibitor which was approved with a composite CR rate of 21%.
Speaker Change: And it's important to remember that this 21% rate was in an ideal population of patients, predominantly naive, to flip three inhibitions.
Speaker Change: The M. of Usertib study on the other hand was in salvage line patients.
Over 80% of the patients on M.A.V.R.T.A.
had already been treated with a flit 3 inhibitor.
and failed.
Speaker Change: We believe the reason M.O. research of data were so compelling is its novel mechanism of action.
It blocks both Iraq IV and Fleet III.
Speaker Change: For several years, it has been suggested in the literature that Blocking Ira Q4 can enable patients to overcome adaptive resistance to flip 3 adhibition.
These clinical data clearly support that thesis.
Speaker Change: Finally, I'd like to provide an update on our progress with the triplet study in Frontline AML.
Speaker Change: As a reminder, in 2024, we initiated a Phase I study of M.A.V. assertive as an add-on agent to Pheneticlox and A.S. deciding in front line-and-out.
Speaker Change: This study is assessing safety and tolerability, where M.O.V. assertive is added to a patient's venesa regimen in 7, 14, and 21-day dosing regimens after they have achieved a CR on venesa and while they remain positive for minimal residual disease.
Speaker Change: 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.
Speaker Change: We look forward to providing you with additional updates as the year progresses.
Speaker Change: With that, I'll turn the call over to Diantha for the financial update. Diantha?
Diantha Duvall: Thank you, Jim. Gears 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 $2.3 per share for the same period in 2023.
Diantha Duvall: Curis reported 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.
Diantha Duvall: 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 upset by higher manufacturing costs [inaudible]
Diantha Duvall: 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.
Diantha Duvall: General 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-weighted costs.
Diantha Duvall: DNA expenses were $16.8 million for the 12 month ended December 31, 2024, compared to $18.6 million for the same period in 2023.
Diantha Duvall: In October , we completed a registered direct offering and concurred private placement with net proceeds of approximately 10.8 million.
Diantha Duvall: On March 28th, 2025, we priced a registered direct offering in concurrent private placement of common stock pre-funded warrants and warrants with gross proceeds of approximately $10 million.
Diantha Duvall: The impact of these two offerings has extended our cash run away into the fourth quarter of 2025. With that, I'd like to open the call for questions. Operator?
Speaker Change: Thank you, ladies and gentlemen, and we will now begin the question and answer session. As a question, you may press a star, followed by the number one on your telephone keypad.
Diantha Duvall: If you're using a speaker phone to speak up your hands before pressing any keys.
Diantha Duvall: Do we draw your question? You may press a star, followed by the number two.
Speaker Change: With that, our first question comes from the line of Pripyat, the Verapunder, with true securities
Hi, good morning. This isn't cool, I'm in for a cup of...
Speaker Change: Can you just talk a little bit more about cash, one-way, and how we should speak and see about expenses going forward or any additional cost nodulations we should be considering as the data models? Yeah, actually, Diantha, why don't you walk through that?
Absolutely. So, we've previously guided that our cash, our, um...
Speaker Change: Our burn is about 10 million a quarter, and that continues to be the case. So again, 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.
Speaker Change: I think we're in one quick follow-up. Can you just talk about any potential inbound interest from partners in this environment? Are there any additional hurdles for partnerships other than fitting into the landscape?
Speaker Change: Sure, as you can imagine, given the utility that we've seen so far at NHL NAML, we're on radar screens, I would say just as a matter of course.
Speaker Change: 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.
Speaker Change: And your next question comes from the line of Sean McCutcheon with Raymond James, please go ahead
Chanda Kachan: Hey guys, thanks for the questions. Can you remind us how many primary central systems
Speaker Change: Either as Monotherapy or in combination with the Brutonib and perhaps walk us through the necessary steps to meet the FDA's requirement on the individual component contributions.
Speaker Change: and, you know, obviously based on your commentary, you know, 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?
Yeah, actually Jonathan, you're probably the best to address that one.
Jonathan Zohn: Sure. So to date, we've dozed 13 patients at 100 milligrams. Those patients have been dozed in part B of the study.
Remind me of your second part of the question.
Jonathan Zohn: The second part was just the, you know, deceptual need in order to meet the DEFD's requirement on the individual component contributions, and then, you know, roughly the number of patients you expect to need within the U.S. at a go for a dose.
Jonathan Zohn: So we would expect that the U.S. and Europe will be using similar data and when we think about the dose selection we'll be able to make that after about nine patients that have been dosed on 100 and 200.
All right, thanks.
for the lead watcher.
You might be a mute.
Speaker Change: 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 terms of the response rates that you have mentioned. Thank you.
Jonathan Zohn: Sure. Well, when did I start on that, and then I'll ask Jonathan to appoint as well.
Speaker Change: So I think what both agencies, clearly I think we're so supportive of our efforts to bring a treatment to primary scene as lymphoma based on the data that we've seen today and the data that we've seen today are very compelling.
Jonathan Zohn: Obviously, we would be hoping that as we complete enrollment in the study that the data remain consistent and that the compelling results that we've seen to date hold as we finish out enrollment in that study. I'm Jonathan, would you like to add your thoughts?
Jonathan Zohn: The only thing I would add is, you know, both agencies clearly acknowledge there are no approved treatments in this space [inaudible]
Jim Dentzer: and I think that's why we had, you know, favorable discussions with them. And as Jim mentioned, you know, where the response rate is today, you know, as long as we are probably north of.
Speaker Change: I'm going to be doing a video on how to make a new new new new new new new new new new new new new
Great. Thank you very much.
Speaker Change: Your next question comes from the line of Edward with H. Seawain Wright, please go ahead.
Ed White: Hi, thanks for taking my questions. You just had mentioned the agency's looking for North of 25% ORR. Is this a bit of a change? I think in the past you've mentioned that they're looking for a CR rate above 20%.
Ed White: Now, let me add to that and then I'll ask Jonathan to pine 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 an all hypothesis of 10%.
Ed White: So, 20% clearly does that. We're much higher than that now. I think if we end up somewhere in a 25% range, 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
Ed White: 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 good position.
Jonathan, do you want to add your thoughts on that?
Yeah, nothing to add to that gym, that's a fact.
Speaker Change: Thank you. How should we be thinking about taking leukemia? It seems like you're focusing on PC and SL patients. Should we expect to see more enrollment in the leukemia study and also should we expect to see more data later this year?
Speaker Change: Yeah, so I want to be more cautious about what kind of data in leukemia they'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 Flip 3.
Speaker Change: So, on the triplet study, as we mentioned 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.
Speaker Change: And that's the critical item in that study. Make sure we can show that adding M. of assertive to current standard of care is safe and tolerable.
Speaker Change: 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 Emma.
Speaker Change: does the same thing in the clinic that it did in the lab, and that is that it added efficacy to the venues 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
Speaker Change: A monotherapy extension into the Flip 3 population, you know, it looks as though at this point the data we have suggests M of assertive is the best in class, Flip 3, drug as a monotherapy which makes sense, right? It's the only drug that blocks Ira Q4 and Flip 3, so it should be the best in class.
Speaker Change: 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.
Speaker Change: I would look forward, hopefully, as with the year progresses and we make progress in getting those studies initiated, we have a better sense of timelines and can be able to set for you what data we would expect one. Does that make sense?
Yes, thanks, Jim. Great, thanks, Ed.
Speaker Change: 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.
James Dentzer: 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 this important drug. We appreciate your time today and we look forward to providing updates in the near future.
Operator.
James Dentzer: 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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