Curis, Inc. (CRIS) Earnings Call Transcript & Summary

Thanks for joining us, and welcome to the business update call for Curis' fourth quarter of 2024. First off, I'd ask that each of you visit the Investors portion of our site, www.curis.com, where you can locate the press release covering our fourth quarter 2024 business update along with the accompanying financial tables. Also, a reminder that forward-looking statements will be part of this call, and those rest upon what we currently expect and believe. Certain risks and uncertainties apply to these statements, and actual results could end up differing materially. Please consult our SEC filings for additional details. With me today are Jim Dentzer, our President and Chief Executive Officer, and Jonathan Zung, our Chief Development Officer. A question-and-answer period will also take place once the call concludes. At this point, I'd like to hand things over to Jim.

Thanks, Diantha. Hello, everyone, and good morning — glad you could join Curis' call covering our fourth quarter business update. During this quarter, we achieved significant strides across both NHL and AML. Starting with TakeAim Lymphoma, our study assessing emavusertib combined with ibrutinib for PCNSL. Prior to getting into the clinical results, I want to draw attention to the positive feedback that came to us from the EMA and FDA regarding the possibility of conditional marketing authorization in Europe along with accelerated approval here in the U.S. To recap, we approached both agencies about the prospect of accelerated filings following the first early data from PCNSL patients who received emavusertib plus ibrutinib during the prior year; meetings with the agencies took place in the second half of 2024, and we are happy to report that both reviewed our proposed plans and gave feedback regarding the possibility of an accelerated approval pathway founded on our ongoing TakeAim Lymphoma study. To reiterate, this trial is single-arm and open label, running in the U.S., EU, and Israel, with ORR serving as the primary endpoint. Both agencies concurred that patients who are already enrolled in the trial may be included in the submission provided they satisfy the same inclusion/exclusion criteria; they likewise offered useful direction on supplemental information, for instance contribution of effect, that should be part of the submission, plus preliminary thinking regarding how our confirmatory study ought to be designed. To put it briefly, those discussions proved extremely productive. The timeline for developing emavusertib has just been sped up. Our present Phase1/2 study now qualifies as registrational for both the U.S; and Europe. Clearly, this is the result we had hoped for, and with over 30 clinical sites currently open for enrollment, our aim is to finish enrollment within the coming 12 to 18 months. Now, moving on to the clinical data. As a reminder, we are evaluating the emavusertib ibrutinib combination across two separate PCNSL populations: patients who are BTKI naïve and those who are BTKI experienced. The rationale behind pairing emavusertib with ibrutinib, backed by preclinical as well as clinical data, holds that inhibiting both pathways that propel disease in NHL — the TLR pathway via emavusertib and the BCR pathway via ibrutinib — achieves maximal down regulation of NF-ĸB and may allow patients to attain an objective response even when a BTK inhibitor was given previously and the disease progressed on it. This morning's press release laid out the clinical update covering 27 relapsed refractory PCNSL patients from our TakeAim Lymphoma study, among them 20 BTKI experienced and 7 BTKI naïve patients. For the 20 BTKI experienced patients, tumor burden change data existed for 13 at the cutoff date. Out of those thirteen, nine showed a decrease in tumor size. That included six objective responses: four complete responses and two partial responses. Three of the four CRs lasted more than half a year. When it came to the seven patients who hadn't previously received a BTKI, we had tumor burden change information for six of them as of the cutoff date. Five of those six saw their tumor burden go down, and that figure covered five objective responses — one CR and four PRs. All in all, the clinical findings, together with the guidance EMA and FDA gave us on the registrational strategy we put forward, leave us very encouraged. Over the next 12 to 18 months, we'll focus on enrolling another 30 to 40 patients to support a filing for accelerated approval. Last, to close out what we accomplished in NHL this quarter, we are happy to report that emavusertib received Orphan Drug Designation for primary CNS lymphoma in the U.S. as well as in Europe. That brings me to AML. At the December ASH conference, Dr. Eric Winer of Dana-Farber shared findings on 21 patients carrying a FLT3 mutation, all of whom had undergone fewer than three prior lines of therapy and were given emavusertib as monotherapy at the RP2D of 300 mg bid. Those results showed that in the salvage line setting, the composite CR rate came to 38%, with 10 objective responses out of 19 patients who could be evaluated for response: six complete CRs, two CRs accompanied by partial or incomplete hematological recovery, and two morphologic leukemia free state responses. What we found especially encouraging was the speed at which those responses occurred, since 7 of the 10 responses were already reported at the first assessment. To put that in context, FLT3 patients who are relapsed or refractory typically receive gilteritinib, a FLT3 inhibitor approved on the basis of a 21% composite CR rate, and it is worth keeping in mind that this 21% came from an ideal patient population that was largely naïve to FLT3 inhibition. The emavusertib study, in contrast, enrolled salvage line patients. Over 80% of the patients who received emavusertib had already tried a FLT3 inhibitor before, and it didn't work for them. What we believe makes the emavusertib results so striking is the way it works, which is novel: it inhibits both IRAK4 and FLT3. For a number of years, the literature has indicated that inhibiting IRAK4 could help patients get past adaptive resistance to FLT3 inhibition. The clinical findings we have clearly back up that idea. Finally, I'd like to bring you up to date on the status of the Triplet Study in Frontline AML. Just to recap, during 2024 we started a Phase 1 trial testing emavusertib as an added treatment alongside venetoclax and azacitidine for Frontline AML. This trial looks at how safe and tolerable it is when emavusertib gets incorporated into a patient's ven/aza routine using 7, 14, and 21 day dosing schedules, once they've reached a CR while on ven/aza and continue showing minimal residual disease positivity. The seven day group has been fully enrolled, and we're still signing up participants for the 14-day group. Basically, 2024 turned out to be quite fruitful, and we've kicked off 2025 carrying good energy forward. We're eager to share more news with you as the months go on. Having said that, I'll now hand things over to Diantha to walk us through the financials. Diantha?

Thanks, Jim. For the fourth quarter of 2024, Curis posted a net loss of $9.6 million, which works out to $1.25 per share, versus a net loss of $11.7 million, or $2.03 per share, during the same period in 2023. Over the 12 months ended December 31, 2024, Curis recorded a net loss of $43.4 million, or $6.88 per share, compared with a net loss of $47.4 million, or $8.96 per share, for the same period in 2023. Research and development expenses came in at $9 million for the fourth quarter of 2024, down from $10 million for the same period in 2023. That decline was mainly driven by lower clinical, research, consulting and employee related costs, partly offset by higher manufacturing costs. For the 12 months ended December 31, 2024, R&D expenses totaled $38.6 million, 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. This decrease was primarily due to lower legal, facility, consulting and employee related costs. For the 12 months ended December 31, 2024, G&A expenses reached $16.8 million, compared to $18.6 million for the same period in 2023. During October, we closed a registered direct offering and concurrent private placement, generating net proceeds of roughly $10.8 million. Then 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. Thanks to the impact of these two offerings, our cash runway now extends into the fourth quarter of 2025. With that, I'd like to open the call for questions. Operator?

Hi there, good morning — Nicole here, filling in for Kripa. Could you expand a bit more on the cash runway, and how we ought to think about that expenses line moving ahead, plus any further cost adjustments we should be factoring in as we refresh our models?

Sure — in fact, Diantha, would you mind taking us through that?

Yes, certainly. We had said before that our burn runs roughly $10 million each quarter, and that's still true. So once more, the money raised from those two offerings we completed in the fourth quarter of last year and the first quarter of this year pushes our cash runway out from mid '24 to 4Q of '25.

All right, that's helpful. Just one brief additional question. Could you share a few thoughts on whether partners might be reaching out with interest given the current conditions? Beyond the question of how a partnership would fit within the broader landscape, are there any other obstacles to consider?

Certainly. As you might expect, with the value we've demonstrated thus far in NHL and AML, people are paying attention to us. I'd put it this way — as a normal part of how we operate, we anticipate that conversations will keep happening regarding the best way to advance our program. And eventually, my guess is that this will mean teaming up with one of the big companies active in either the NHL or AML arena. Keep watching for more.

Thank you very much.

Hello everyone, and thanks for sending in your questions. Could you give us an update on the total number of primary central nervous system lymphoma patients who have received emavusertib at a dose of 100 milligrams BID up to now, whether that was administered alone or together with ibrutinib? And maybe you could take us through the steps that would be required to satisfy the FDA regarding the contributions of the individual components. Clearly, from what you've said, the number of patients needed is a review matter. But going forward at the chosen dose, would you expect that number to be approximately what the EMA is looking for? Thank you.

Yes, Jonathan, you're probably in the best position to take that question.

All right. So up to now, 13 patients have received a 100-milligram dose. Those individuals were given the drug in Part B of the trial. Could you repeat the second portion of your question for me?

The second item I had was simply the actions required for satisfying the FDA's mandate regarding contributions from each individual component, and then approximately how many patients you anticipate needing inside the U.S. at the go-forward dose?

Right. So our expectation is that similar data will be utilized by both the U.S. and Europe. And regarding picking the dose, we will be in a position to do that once roughly nine patients have received dosing at 100 and 200.