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

Thanks for joining us for Curis' business update covering the second quarter of 2024. To get started, I'd ask that you visit the Investor portion of our site, www.curis.com, where the press release for our second quarter 2024 business update sits alongside the associated financial tables. I also want to note that forward-looking statements will be part of what we discuss today, and those rest on what we currently expect and believe. Certain risks and uncertainties apply to these statements, so actual results could come out materially different. Our SEC filings contain further details. With me on the call today are Jim Dentzer, our President and Chief Executive Officer, and Jonathan Zung, our Chief Development Officer. A question-and-answer period will also be held once the call concludes. At this point, I'll hand things over to Jim.

Appreciate that, Diantha. Good morning to all, and thanks for joining Curis’ call covering our second quarter business update. We’ll begin with the TakeAim Lymphoma study, in which emavusertib is being tested alongside ibrutinib among relapsed/refractory PCNSL patients who have not responded following therapy with a BTK inhibitor. Typically, these individuals have received methotrexate chemo and radiation as front-line treatment, then ibrutinib in the second line. Once patients show progression on ibrutinib, they become eligible to join our trial, where emavusertib gets added to the ibrutinib regimen they are already on. The rationale behind this pairing is scientific: by blocking both pathways that drive NHL — the TLR pathway through emavusertib and the BCR pathway through ibrutinib — patients may be able to achieve an objective response even after progressing while on ibrutinib as a monotherapy. At last December’s ASH conference, we shared data covering the first five patients in this trial, reporting an objective response rate above 50%. Those findings were preliminary yet highly encouraging, particularly considering the substantial unmet need within this population. Enrollment has continued, and as mentioned in this morning’s press release, we have lately begun talks with regulatory authorities to secure alignment regarding the registrational path for emavusertib combined with ibrutinib in primary CNSL. Needless to say, nailing down the registrational path represents a vital next step for emavusertib’s development, and I’m happy with how our latest engagement with FDA went. I’m eager to share the results of those discussions when the timing is right. Talks are advancing in Europe too, and we’re happy to report that emavusertib received orphan drug designation for primary CNS lymphoma from the European Commission; this status brings multiple advantages, such as 10 years of market exclusivity, lower fees for protocol and scientific assistance along with marketing authorization applications, plus a centralized marketing authorization application process through the European Medicines Agency. Even as these regulatory conversations continue, we’re also making superb operational progress, and we expect to hit our goal of 30 clinical sites across the U.S. and Europe, with preliminary data from 15 to 20 patients by year end. Now let’s turn to the TakeAim Leukemia study, which tests emavusertib as a monotherapy in relapsed/refractory AML patients. Earlier this year at ASCO and EHA, we gave updated data on two patient groups within this study: those with a splicing factor mutation and those with a FLT3 mutation. Among the splicing factor mutation group, four of 18 evaluable patients saw an objective response, comprising one complete remission or CR, two CRs with partial hematologic recovery, or CRh, and one morphologic leukemia-free state or MLFS. In the FLT3 group, six of 11 evaluable patients saw an objective response, comprising three CRs, one CRh, and two MLFSs. Also worth noting, three of those patients had not previously been treated with a FLT3 inhibitor. Every one of those 3 patients showed an objective response, and among the other 8 patients — the ones whose earlier therapy with a FLT3 inhibitor had not worked — 3 managed to obtain an objective response on emavusertib; in our view, these results back emavusertib’s novel mechanism along with its promise as a therapy for people who have relapsed/refractory AML. Turning to the frontline setting, you might recall that preclinical findings show a synergistic effect whenever emavusertib is given together with azacitidine and venetoclax, which is the standard-of-care in frontline AML. A study of this triple combination — meaning emavusertib plus azacitidine and venetoclax in frontline AML — was started by us not long ago. Initial safety data from that study should be available later this year, we anticipate. All in all, the advances across both our TakeAim Leukemia and TakeAim Lymphoma studies make me very happy, and I’m eager to share further updates as the year moves along. Having said that, I’ll hand the call to Diantha for the financial update.

Thanks, Jim. Curis posted a net loss of $11.8 million, which works out to $2.03 per share, versus a net loss of $12 million, or $2.47 per share, during the equivalent quarter in 2023. For the six months that closed on June 30, 2024, Curis recorded a net loss of $23.7 million, or $4.08 per share, compared with a net loss of $23.5 million, or $4.87 per share, over the same span in 2023. R&D expenses came in at $10.3 million in Q2 2024, against $10 million in the matching quarter of 2023. Over the six months ending June 30, 2024, R&D expenses reached $19.9 million, versus $19.2 million across the comparable stretch of 2023. G&A expenses amounted to $4.8 million in the second quarter of 2024, compared with $4.2 million in the same quarter of 2023. For the six months concluding June 30, 2024, G&A expenses were $9.7 million, versus $9 million during the equivalent period in 2023. The growth in both R&D and G&A spending stems mainly from elevated employee-related costs. Curis' cash, cash equivalents and investments came to $28.4 million, with roughly 5.9 million shares of common stock outstanding; we anticipate that our current cash, cash equivalents and investments ought to fund our planned operations into the first quarter of 2025. On that note, I'd like to turn the call over to questions. Operator?

Morning, and thank you for fielding this. Also, congratulations on everything that's been accomplished. I have a couple of things. First, regarding the PCNSL data readout expected near the close of the year, what bar do you have in mind for moving the program ahead? Put differently, which guidepost are you watching for? Then I have one more after that.

Sure — a quick reminder, Yale. And thanks, incidentally, for joining the call to ask. Keep in mind that our target population is patients whose disease progressed after a BTK inhibitor. Let's frame it properly. First-line therapy didn't work for them. The BTK inhibitor didn't work for them. Had we put them back on the BTK inhibitor — essentially repeating that identical option — naturally, there would be no response. What we hope to demonstrate is whether objective responses can be achieved at all. Of course, I recognize results so far have come in considerably stronger than that, but for patients, I'd say the bar comes down to this: can we prove the thesis is sound — that despite prior failure on a BTK inhibitor, the addition of emavusertib shifts that regimen's efficacy in a fundamental way. That is truly what we're after.

All right.

And naturally, when you're dealing with a bigger patient population, correct? Naturally.

Sure. And you're expecting roughly 15 patients, maybe at minimum, around when you share the results?

Correct.

All right. And I guess my next question relates to the leukemia side — congratulations on everything the positive results showed previously. From what I understand, you said there are various paths available moving forward, clearly based on what the data looks like when it comes out soon. A few of those paths regarding plus three — you could go with either the naïve patient group or heavily pretreated patients, or also for the FFM < >, you would clearly be dealing with patients who have prior exposure in that setting only. How do you think about the different choices, or perhaps you'd rather pursue all of them leading into 2025?

Sure. So, as you're aware, when it comes to leukemia, there's greater optionality, and that's a lucky result of how the molecule was designed, correct? The reason being that the molecule targets IRAK4, which nearly every patient expresses.

Hi there? Can you hear me?

Operator, Jonathan Zung here, calling from Curis. Jim is attempting to reconnect.

We’re back in, Jonathan.

Okay.

I'm not certain what took place. The line dropped us from the call. So I was in the middle of replying to Yale Jen's question. Yale, maybe you can tell me the point at which I was cut off?

Absolutely, that's fine. Now, regarding question two: when it comes to leukemia, there are several paths you could weigh — for FLT3, whether you'd aim at treating either the naïve group — naïve or those who've had prior treatment — and then for the FFM, which you'd obviously only give to patients already treated before. So out of those three choices…

All right.

… I suppose you could pick whichever you like — first, second, or both?

Sure. Let me share a few reflections. To start, we should address frontline therapy, which means the combo, and after that monotherapy involving FLT3 on its own, and then inside FLT3, naturally, we’d split things into distinct cohorts — one for naïve patients and one for those who are experienced.

Sure.

As you're aware, the molecule's appeal in leukemia partly stems from its action against IRAK4 and FLT3. IRAK4 shows up in almost every AML patient, and FLT3 — well, we know that mutation appears in about one-third of that group. Given this distinctive targeting, our view is that it might work as a standalone treatment in leukemia, unlike in the frontline setting, where we expect it to reach all comers alongside azacitidine and venetoclax, and naturally in non-Hodgkin's lymphoma paired with ibrutinib. When we examine monotherapy within the FLT3 subgroup, your point is spot on. It might suit both treatment-naïve and previously treated individuals. With unlimited resources, pursuing every one of those groups would naturally be perfect. At year-end, when we share a fuller readout of the dataset at ASH, one topic we'll certainly take up is which groups we'll choose to push hardest going forward. So I'd suggest watching for that conversation, though every one of those possibilities lies ahead of us.

All right, that's a big help. Perhaps I can squeeze in just one more — regarding IRAK4 work, what stands out most for the next event coming up?

Sure. When it comes to the IRAK4 symposium, we're delighted to be holding it once more this year. The way you know, excitement around IRAK4 generally has climbed within academia annually from the time we began putting out publications on IRAK4's usefulness in oncology. This year, I believe we have a truly excellent mix of participants, with leukemia specialists, lymphoma specialists, plus attention given to solid tumor efforts; so the clinical results Curis has concentrated on today, and in our public forums, really center on leukemia and lymphoma, since that's where our clinical results sit. Yet we also have five ISTs running in solid tumors, and there's an abundance of genuinely compelling preclinical results, with a number of them now starting trials in patients too; so over the months, quarters, and years ahead, I anticipate that will grow into a more and more significant and fascinating piece of the story.

All right. That's quite useful, and congratulations on the advancement. I'm eager for ASH to hear further specifics.

Thanks a lot.

Morning. I appreciate you taking my question. Jim, during your comments on TakeAim Lymphoma, you said you'd just had a meeting with the FDA about the registrational pathways. I'm curious what your thinking is regarding the regulatory route you'd consider optimal? Thanks.