Curis, Inc. (NASDAQ:CRIS) Q1 2024 Earnings Call Transcript May 7, 2024

Curis, Inc. misses on earnings expectations. Reported EPS is $-2.0534 EPS, expectations were $-1.94. CRIS isn't one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Good morning, ladies and gentlemen, and welcome to the Curis First Quarter 2024 Business Update. At this time all lines are in listen-only mode. Following the presentation we will conduct a question-and-answer session [Operator Instructions]. This call is being recorded on Tuesday, May 7, 2024. I would now like to turn the conference over to Diantha Duvall. Please go ahead.

Diantha Duvall: Thank you, and welcome to Curis' First Quarter 2024 Business Update Call. Before we begin, I would like to encourage everyone to go to the Investors section of our website at www.curis.com to find our first 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 today on today's call are Jim Dentzer, President and Chief Executive Officer; Bob Martell, Chief Scientific 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.

Jim Dentzer: Thank you, Diantha. Good morning, everyone, and welcome to Curis' Q1 business update call. This quarter, we made significant progress in advancing emavusertib in our three key areas of focus. First, as a monotherapy in patients with relapsed refractory AML and with a FLT3 or splicing factor mutation in our TakeAim Leukemia study. Second, as a doublet therapy for patients with relapsed/refractory primary CNS lymphoma, combining emavusertib with ibrutinib in our TakeAim lymphoma study. And third, as a triplet therapy in frontline AML for all comers regardless of mutation status, that combines emavusertib with azacitidine and venetoclax. Next Tuesday, in connection with the EHA conferences publication of accepted abstracts, we expect to provide a top line update of clinical data from our TakeAim leukemia study.

Previously, we had disclosed data for five patients. Three patients with a FLT3 mutation and three patients with a splicing factor mutation, including one patient with both a FLT3 and a splicing factor mutation who was included in both populations. Our update next week will report data for 25 new patients, bringing the total to 30 relapsed/refractory AML patients treated with emavusertib as a monotherapy. A mutation status for these patients is 12 patients with a FLT3 mutation and 20 patients with a splicing factor mutation, including two patients with both a FLT3 and a splicing factor mutation who are included in both populations. We look forward to discussing the top-line data for these patients on an investor call when the data are released, followed by more detailed presentations at the ASCO and EHA medical conferences that more fully explore emavusertib's potential to outperform, as a single agent the benchmarks for existing therapies in genetically targeted AML populations.

In the relapsed refractory FLT3 population, the benchmark for FLT3 inhibition is gilteritinib which its FDA label demonstrates, can achieve a 21% CR/CRh rate in patients who have failed frontline therapy. With emavusertib, our goal is to beat that benchmark. We think this is possible, even though the majority of patients in our study have failed prior treatment with a FLT3 inhibitor because unlike existing treatments, emavusertib targets both FLT3 and IRAK4, the [escape path] (ph) for FLT3. This is the central hypothesis of the molecules designed and is demonstrated in the preclinical data. With the 12 patients we'll be showing at ASCO EHA, we hope to further support that hypothesis, namely that emavusertib has a potential to establish a new and best-in-class benchmark for the FLT3 AML population.

As we move to the relapsed/refractory splicing factor population, we find that the benchmark is unfortunately for these patients far lower. There are no drugs approved. Expected survival is only a few months and existing treatments are ineffective. The only study published for relapsed/refractory AML patients with a splicing factor mutation, was for patients treated with the Aza-ven doublet. It was a very small study with only five patients, and the response rate was 0. This is especially notable as Aza-ven is standard-of-care in frontline AML for patients ineligible for intensive induction. We hope emavusertib's novel mechanism can show clear single agent activity in this very challenging population. Anything that shows emavusertib can be 0% benchmark set by Aza-ven would be positive.

In our expanded data set, we'll be looking for blast count reductions, neutrophil increases platelet increases, objective responses and ultimately, of course, extended survival. As we turn to our TakeAim lymphoma study, we see significant progress there as well. At the most recent ASH conference, we presented data for five patients with relapsed/refractory primary CNS lymphoma, who had failed prior treatment with a BTK inhibitor. We expect to provide an update with additional data later this year, most likely at the ASH conference in December. Previously, we have said we expected to report data on 10 to 15 patients. Today, we are pleased to refine that estimate to the high end of the range, as we now expect to report data for approximately 15 relapsed/refractory primary CNS lymphoma patients, who have failed prior treatment with a BTK inhibitor.

We are also pleased to announce the advancement of our triplet study in all comers in frontline AML. We have begun enrollment and expect to have preliminary safety data later this year again, most likely at the ASH conference in December. The excitement around this frontline study stems from the novel targeting of IRAK4, and builds upon the clear anticancer activity we are seeing in our monotherapy studies. We know IRAK4 is an important target in AML and that neither azacitidine nor venetoclax addresses it. So the logical next step is to explore the [Aza-ven] (ph) triplet and its potential to establish a new benchmark for frontline therapy in all comers in AML. In summary, we're encouraged by our progress across the board in leukemia and lymphoma and we look forward to reporting our updated leukemia data next week.

With that, I'll turn the call back over to Diantha to review our results for the quarter. Diantha?

Diantha Duvall: Thank you, Jim. For the first quarter of 2024, Curis reported a net loss of $11.9 million or $2.05 per share as compared to a net loss of $11.6 million or $2.39 per share for the same period in 2023. Research and development expenses were $9.6 million for the first quarter of 2024 as compared to $9.1 million for the same period in 2023. The increase in research and development expenses were primarily attributable to higher employee related costs. General and administrative expenses were $4.9 million for the first quarter of 2024 as compared to $4.8 million for the same period in 2023. As of March 31,2024, Curis' cash, cash equivalents and investments totaled $40.7 million and there are approximately 5.9 million shares of common stock outstanding.

We continue to be in a solid cash position and expect that our existing cash, cash equivalents and investments should enable us to maintain our planned operations in 2025. With that, I would like to open the call for questions. Operator?

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