Q3 2024 Curis Inc Earnings Call
Good morning, ladies and gentlemen, and welcome to the curious third quarter 'twenty 'twenty four business update call.
At this time all lines are in a listen only mode. Following the presentation. We will conduct a question and answer session. If at any time. During this call you require immediate assistance. Please press star zero for the operator.
Speaker Change: This call is being recorded on Thursday November 14th 2024, I would now like to turn the conference over to Diantha Duvall curious Chief Financial Officer. Please go ahead.
Thank you and welcome to curious as third quarter 'twenty 'twenty four business update call before we begin I would like to encourage everyone to go to the investors section of our website at Www Dot curious dot com to find our third quarter 'twenty 'twenty four 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 upon 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 Zhang 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.
Jim Dentzer: Thank you Dan.
Jim Dentzer: Good morning, everyone and welcome to curious as third quarter business update call.
Jim Dentzer: Let's start with our T game lymphoma study, which is evaluating <unk>, who started in combination with ibrutinib in relapsed refractory P. C. N S. L patients that have failed after treatment with the beat TK inhibitor.
Jim Dentzer: These patients are generally treated with methotrexate based regimen, which includes chemo or radiation in the frontline setting.
Jim Dentzer: Followed by a b TK inhibitor, when a patient's disease progresses.
Jim Dentzer: It's when this treatment fails in the salvage line setting.
Jim Dentzer: The patients become eligible to enroll in our study.
Jim Dentzer: And receive Emma who started in combination excuse me with Ibrutinib.
Jim Dentzer: The thesis for this combination which is supported by both preclinical data and our early clinical data.
Jim Dentzer: Is the blocking both of the pathways driving NHL walking the T L. Our pathway with him a concerted and blocking the PCR pathway with Ibrutinib.
Jim Dentzer: Can enable patients to achieve an objective response, even after they have progressed on ibrutinib.
Jim Dentzer: In September at the third annual Iraq for symposium in cancer.
Jim Dentzer: We released an update of our P. C N S. L data with 10 Evaluable patients.
Jim Dentzer: These data showed three complete responses Crs one.
Jim Dentzer: One unconfirmed complete response C R U and.
Jim Dentzer: And two partial responses or P r's.
Jim Dentzer: The duration of response for three of the four patients with a C. R. C argue was greater than six months.
Jim Dentzer: These data are very early but also encouraging, especially given the high unmet need in this population.
Jim Dentzer: We continue to enroll patients in this study.
We are actively engaging with regulatory authorities to gain alignment on the Registrational path.
As a reminder, this study is being run in the U S Europe and Israel.
It goes without saying that defining the registrational path to approval is a critical next step in <unk> development and I'm pleased with the progress we're making.
Jim Dentzer: Now, let's move onto our taking them leukemia study, which is evaluating <unk> as monotherapy in patients with relapsed refractory AML.
Jim Dentzer: And ask on Ehow earlier this year, we provided updated data for patients with a flip three mutation.
Jim Dentzer: These data showed six of 11 Evaluable patients achieved an objective response, including three Crs, one CRH and to MLR passes.
Jim Dentzer: Also of note.
Jim Dentzer: Three of the 11 patients were naive to treatment with a plus three inhibitor. All three of these patients achieved an objective response.
Jim Dentzer: And three of the remaining eight patients those who had failed prior treatment with a <unk> three inhibitor achieved an objective response.
Jim Dentzer: At the Ash meeting next month and expanded dataset of 19 response Evaluable patients will be presented by Derek by Dr. Eric Winer from Dana Farber in an oral presentation on Monday December night.
Jim Dentzer: We will also be providing updated data for our study in patients with high risk Mds.
Jim Dentzer: In a poster by lead author Dr. Guillermo Garcia Manero from M. D Anderson being presented on Sunday December eight.
Jim Dentzer: Overall, I'm very pleased with the progress and both are taking them leukemia and take aim lymphoma studies.
Jim Dentzer: Look forward to providing additional updates as the year progresses.
Jim Dentzer: With that I'll turn the call over to Dan for the financial update anthem.
Speaker Change: I'm curious reported a net loss of $10 1 million or $1 70 per share for the third quarter of 2024 compared to a net loss of $12 2 million or $2 13 per share for the same period in 2023.
Speaker Change: Your support and a net loss of $33 8 million or $5 77.
Speaker Change: Seven cents per share for the nine months ended September 32024, compared to a net loss of $35 7 million or $6 96 per share for the same period in 2023.
Speaker Change: Research and development expenses were $9 7 million for the third quarter of 2024 compared to $10 4 million from the same period in 2023.
Speaker Change: The decrease was primarily attributable to lower consulting and employee related costs.
Speaker Change: R&D expenses were $29 6 million for the nine months ended September 30 of 2024 compared to $29 5 million for the same period in 2023.
Speaker Change: General and administrative expenses were 38 were $3 8 million for the third quarter of 2024 compared to $4 8 million for the same period in 2023 the decrease.
Speaker Change: This was primarily attributable to lower legal and employee related costs.
Speaker Change: G&A expenses were $13 4 million for the nine months ended September 32024, compared to $13 8 million for the same period in 2023.
Speaker Change: In October we completed a registered direct offering and concurrent private placement of unregistered warrants with net proceeds of approximately $10 8 million.
Speaker Change: Including the impact of the October 2024 offerings curious as cash and cash equivalents totaled $31 6 million and the company had approximately $8 5 million shares of common stock outstanding.
Speaker Change: <unk> expects its existing cash and cash equivalents will enable its planned operations in the mid 25.
Speaker Change: With that I'd like to turn the call over for questions operator.
Speaker Change: Okay.
Speaker Change: Thank you, ladies and gentlemen people will now begin the question answer session should you have a question. Please press star followed by the number one on your Touchtone phone, you'll hear a problem at your hand is erased should you wish to declines on the polling process. Please press star followed by number two.
We're using a speaker phone please read the handset before pressing any keys.
Speaker Change: Once again to ask a question. Please press star followed by number one on your Touchtone phone you will hear a problem that you had has been raised.
Speaker Change: One moment. Please for your first question.
Speaker Change: Your first question comes from the line of Ed White from H C. Wainwright. Your line is now open. Please ask your question.
Good morning, Thanks for taking my questions good morning.
Speaker Change: Good morning, Jim.
Speaker Change: So you had mentioned that you're working to gain alignment with the FDA.
Speaker Change: In K C N S L.
Speaker Change: But you know sort of implies that you're out of alignment.
So what needs to be done right now to get into alignment.
Speaker Change: And what is the ideal pathway to approval in your mind.
Speaker Change: Sure. So I Wouldnt say were out of alignment by any stretch no I'd just say, we're engaging in the discussions.
Speaker Change: I think what we see and we've said this in the past on calls.
Speaker Change: In the early days earlier this year as we started to get the first data in these patients. We saw that we were seeing results in salvage line therapy that were frankly, better than we expected and better than second line and even though it was a small number of patients.
Speaker Change: We wanted to reach out directly to the FDA to see if we couldn't have an accelerated path.
Speaker Change: For this drug you know the normal path of approval is you've completed phase one two study you run all the reports you have an end of phase meeting with FDA.
Speaker Change: And then talk with the FDA about the Rep Registrational design looks like.
Speaker Change: We thought that given there is such a critical unmet need no drugs approved for this.
Speaker Change: In the salvage line data that we're getting look.
Speaker Change: Look frankly terrific that we might have a faster path. So that's the discussion we're having right now is.
Speaker Change: Can we have an accelerated approval path and if so what does that look like.
Speaker Change: My hope is that those discussions are in my view hopefully going to be in a position, where we'll have some clarity in Q1.
Speaker Change:
Speaker Change: But we'll remain to be seen I think at this point. We're just excited by the data and we're pleased that the FDA is is engaged with us on identifying.
An accelerated or at least a faster path.
Speaker Change: Great. Thank you, Tim and the anthem, maybe a question for you.
Speaker Change: G H.
Speaker Change: General administrative costs were down about $1 million quarter over quarter, and R&D was down about a half a million.
Speaker Change: As you know you continue to advance in the clinic.
Speaker Change: How should we be thinking of expenses going forward not only for the fourth quarter, but how should we be thinking of the cadence of expenses in 2025, I know it might be difficult as youre waiting for FDA guidance, but just wanted to get your initial thoughts on it.
Speaker Change: Thanks, Ed for the question. So you know our historical burn has really been in a call it $10 million to $12 million range. We did some cost modulation earlier in the year that has brought that burned down but.
Speaker Change: But I would expect that the normal burn for tariffs in 2025 should probably stay around that $10 million. The 10 million Mark It will it will vary due to some timing of.
Speaker Change: Factoring them, but for the most part I would sort of assume that sort of $10 million number.
Speaker Change: Yeah.
Speaker Change: Okay.
Okay, great. Thanks for taking my questions you bet.
Speaker Change: Thanks, Ed.
Speaker Change: Your next question comes from the line of Bill John Gerry from Twist Securities. Your line is now open. Please ask your question.
Speaker Change: Good morning.
Speaker Change: We had a question about endless potential on HR Mds, given the abstract that was posted at ash.
Speaker Change: These impressive responses in spite of some mutants, which isn't surprising at this point.
Speaker Change: Data you all have shown but.
Speaker Change: What we want to know what the broader potential A's.
Speaker Change: Given the specific impacts on gene signatures that you've seen.
Speaker Change: Representative mutations in the Mds patient population, we are 10%, 15% or more and give them a round of hasn't read out pursuing a doublet.
Speaker Change: Xander nature, Mds makes sense or HMA and there's M&A. So they just corporate additive enough for that.
Yeah, Hey, Bill Thanks for calling in the great questions. So first yeah. MTS is one of these things that not enough people are paying attention to it is really exciting.
Speaker Change: And we're really looking forward to it as you know, it's a challenging population and until Verona reads out Asia is standard of care.
Once once patients go through that.
Speaker Change: There's really nothing for those patients. So the opportunity is is really terrific. So as you know we've seen a lot of we've seen a lot of responses more marrow Crs ncr's.
We're seeing activity in patients with <unk> mutation patients with spicy mutations.
Speaker Change: At this point.
Speaker Change: We're exploring the possibilities of.
Different dosing regimens and also perhaps combining <unk> with other agents as you say the the Verona readout is going to matter a lot of what that combination looks like but I would say this is an evolving discussion. We're really looking forward to the data update that Dr. Garcia Manero is going to provide at ash.
Speaker Change: And and hopefully it should be a really exciting discussion going into 2025, but yeah. Thank you for paying attention to MTS not as many people see that as we do.
Speaker Change: Thank you.
Speaker Change: Yeah.
Speaker Change: Your next question comes from the line of Lee <unk> of Cantor. Your line is now open. Please ask your question.
Hi team. This is Daniel Bronder unfairly them, we have a question regarding the P. C N F. L trial and the contribution of parts do you think that the FDA might raise that as a as a question.
Speaker Change: And also do you have any.
Speaker Change: Historical data on to be Teekay responses that could help you answer that question.
Speaker Change: Sure. Thank you for the question thanks for the call.
Speaker Change: Yeah.
Speaker Change: Address the.
Speaker Change: First question first and then I'll go to the second one so.
Speaker Change: The short answer is yes.
Discussions with FDA are evolving so we'll have to see how they respond to that but the design of this study is really meant to address that question implicitly.
Speaker Change: So we are taking patients in <unk>.
Immediately after they have progressed on a P T K.
Speaker Change: So the logic would be if you've just progressed at a PTK inhibitor retreating with that same inhibitor should have no effect should have zero response rate you just progressed.
Speaker Change: So by definition.
Speaker Change: Or by design, maybe more accurately.
Speaker Change: The benefit that you receive it is much more likely.
Speaker Change: To be due to the addition of MLP assertive either in its monotherapy capacity or it's synergistic effect, which we believe is at least the thesis suggest is powerful.
Speaker Change: With the beat TK inhibitor. So the first question is yes.
Yes. The FDA, we know is likely to have that question and we'll have that conversation with them and see how that plays into the Registrational design at the same time.
Speaker Change: We're benefiting from the design of the study that is currently in progress, which which does by definition are by design highlight the comparative effect of the two agents and the second question or second part of the question you asked was about PDK and their efficacy.
Speaker Change: There's a lot of literature out there that the largest clinical study to date that was published with Scotia songs study of Ibrutinib in.
Speaker Change: In PC NFL and you may remember in that study in second line.
Speaker Change: Ah patients naive to or be TK, we're able to get a 19% CR rate and a 52%.
Speaker Change: Sure.
Speaker Change: So I said earlier, we were very encouraged that our salvage line data are outperforming that and they are it's it's early days to be fair.
Speaker Change: But we would not have expected they didnt any disease or drug being studied in the salvage line setting without performed second line.
Speaker Change: Yeah, I would say that's why we and why our clinicians are so excited about the possibility of this regimen.
Okay.
Speaker Change: Okay. Thank you so much and if I may ask a follow up another question.
Speaker Change: We were just wondering how are you going to go about the prioritization between your different programs here P. C enough program versus the AML.
Speaker Change: AML and Mds program moving forward.
Speaker Change: That's a fantastic question.
Speaker Change: If I tell you about all the high class headaches, we had a curious I am grateful.
Speaker Change: That we are in the position that the drug works.
Speaker Change: Really where we would expect it to in a number of therapeutic areas. As you know we're studying it in primary CNS lymphoma, we're studying it in AML. We're studying it in Mds. We've also got five ista is going on in solid tumors that are reading out over the next 12 months.
Speaker Change: We have this embarrassment of of investment opportunities an embarrassment of riches.
Speaker Change: And maybe the hardest part of the job to the management team at curious is trying to figure out how to prioritize those I would say at this point in time.
Speaker Change: Because we're in discussions with FDA.
On primary CNS lymphoma, and what that Registrational path looks like I think by definition.
Given the clear unmet need and the data that we're seeing that's got to be a very high priority for us Coincidentally, it's it's a very attractive commercial market as well.
Speaker Change: Beyond that expanding to the other five types of NHL, where beauty case get used.
Speaker Change: That's a really compelling opportunity for us AML and Mds. The data are about to read out at ash. So I'd say with those data in hand, let's have that seem discussion that we're having about NHL.
Speaker Change: What is the best path to approval and how do we engage the regulatory authorities in that discussion and then shortly thereafter, we're going to start getting data in solid tumors.
Speaker Change: It's a great question.
Speaker Change: They were prioritizing primary CNS lymphoma, but it is absolutely a high cost headache for us how to prioritize all of these opportunities.
Speaker Change: Yes.
Okay. Thank you so much for taking my questions you bet. Thank you.
Speaker Change: Your next question comes from the line of CN Mckesson of Raymond James Your line is now open. Please ask your question.
Speaker Change: Hi, guys. Thanks for taking my questions. A couple from me first can you walk us through your current assessment.
Speaker Change: Of what Youll need as far as the data package for primary CNS lymphoma. In particular, what do you think will be a sufficient number of patients in the safety database that the go forward combination with Ibrutinib.
Speaker Change: And Emma.
Speaker Change: How many patients have you currently treated at or above that that dose.
Speaker Change: Do you think 100 patients.
Speaker Change: The rest thresholds.
Speaker Change: Just on precedent and then secondly can you speak to some of the challenges <unk> seen in enrolling the triplet studies, you know whether that would be disposition of the HRD positive CR AML patients.
Speaker Change: Or just in general issues with Avon.
Speaker Change: And timing of the treatment of patients with those with those agents.
Sean: Alright, Thank you Sean.
Sean: So.
Speaker Change: Great questions, Let me start with the primary CNS lymphoma question and then I'll go to the triplet study. So the primary CNS lymphoma study to be honest, that's the whole point of the discussion, we're having with FDA as you know the normal process.
Any drug.
Speaker Change: Going through studies is you run a phase one to do dose escalation.
Speaker Change: When you get those data back follow the patients lock the database produce all the reports go to the FDA have an end of phase meeting talk about the Registrational design and then you go into pivotal.
Given the data we have.
Speaker Change: We thought it it should be and it was worth having a conversation with the FDA to see if they would be interested in running a faster process.
Speaker Change: We are grateful that they agreed to take that call. We're now in discussions.
Speaker Change: In primary CNS lymphoma, theres, not a lot of precedent, but we do know.
There are two studies ongoing right now with a beat TK inhibitor. So ibrutinib is the one that today is the standard of care for <unk> inhibitors, but Oh no.
Speaker Change: Pharmaceuticals has a.
Speaker Change: <unk> inhibitor tier a brute nib.
Speaker Change: Which is approved in Japan for primary CNS lymphoma.
Speaker Change: And is now in its study to get approval in the U S. We know that for that study. It's second line salvage obviously theyre trying to displace ibrutinib.
Speaker Change: And they also have a frontline study that they are using <unk> in combination with methotrexate based regimens.
Speaker Change: In their study.
Speaker Change: The frontline study was end of 75 or is in a <unk> 75.
Speaker Change: The second line study is a 45.
Speaker Change: Presumably.
Speaker Change: Salvage line setting wouldn't need 45.
Speaker Change: Now the question there is of course.
Speaker Change: Given our data from an efficacy perspective that might make sense, but we need to recognize that.
Speaker Change: Bruton has a larger safety database simply because it's already approved in Japan.
Speaker Change: So I don't exactly know where the FDA is going to come out, but we think it's reasonable.
Speaker Change: To suggest that if they are okay.
Speaker Change: With granting us accelerated approval.
That's a smaller study and that then we would have a larger study.
Speaker Change: With perhaps a survival based endpoint in a confirmatory trial.
Speaker Change: All of that's conjecture at this point, we need to finish these discussions and see how the FDA feels about that.
Speaker Change: Got.
I think given the precedent that <unk> has in their study sizes. It makes sense that in this ultra rare indications.
Speaker Change: A small study would be appropriate. It is one of the reasons of course that we chose premier casinos performance now.
Speaker Change: Now on the on the triplet study you had asked specifically about the design.
Speaker Change: With question, where you're looking to have about the design.
Speaker Change: Yeah.
Speaker Change: Yes.
Speaker Change: Just some of the challenges you're seeing in terms of enrollment in <unk>.
Speaker Change: Getting patients progressed on that study and whether that's just a disposition of the <unk> positive CR and all patients or it's more an issue of kind of getting patients who are.
Speaker Change: Our receiving a received a demand in frontline and aren't receiving it.
Speaker Change: Maintenance setting any reticence, you've seen from docs in terms of adding additional agent to an antibody.
Speaker Change: And any insight on your strategy moving forward to kind of boost enrollment there.
Speaker Change: Yes.
Speaker Change: I think you put your finger on it it's not a reticence or safety issue at all it's just how do you find patients who are on <unk>.
Who are in CR.
Speaker Change: And still.
Speaker Change: Already positive.
Speaker Change: And stable enough that they can go into.
Into our study into the triplet.
Speaker Change: At this point in time, what we really want to try and do is accentuate the safety.
Speaker Change: The long term solution to finding all the patients of course go from cycle, One day, one to get the patients to the minute, they're diagnosed and go to a lot of sites.
Speaker Change: We are at a very small number of sites, we're simply looking to make sure that this.
Speaker Change: This combination of EM Asia, and van is going to be safe and tolerable as you know.
Speaker Change: And then are little tricky no two sites dose them the same way anecdotally half of all patients who go on Ace event at some point have to come off for Tolerability not just efficacy.
Speaker Change: We want to make sure that.
Speaker Change: The <unk> combination is tolerable first so that's why we're going after these patients. So it won't take long, we just need a handful of patients and we just wanted to follow them to make sure. We understand it once we do then we then we frankly turbocharged. The study we go to cycle. One day, one we expand the number of sites and at that point once it has been shown to be safe and tolerable.
Speaker Change: No I think the you'll find the physician community is very eager to find something that will increase the potency of that as a N regimen.
Speaker Change: Got it thank you.
Speaker Change: Thank you thanks for the call.
Speaker Change: Okay.
Speaker Change: We do not have further questions at this time, Jim Dentzer. Please continue.
Jim Dentzer: Thank you and thank you everyone for joining us on today's call.
Speaker Change: And as always a special thank you to the patients and families participating in our clinical trials to our team at curious for their hard work and commitment and to our partners, especially at origin and the NCI and the academic community.
Speaker Change: For their ongoing collaboration and support we look forward to updating you again soon.
Speaker Change: Operator.
Okay.
Speaker Change: Thank you. This concludes today's conference call. Thank you for your participation you may now disconnect.