Curis Q1 2025 Earnings Call Transcript

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May 6, 2025

There are 7 speakers on the call.

Operator

Good morning, ladies and gentlemen, and welcome to the Curis Provides First Quarter twenty twenty five Business Update Conference Call. At this time, all lines are in listen only mode. Following the presentation, we will conduct a question and answer session. This call is being recorded on Tuesday, 05/06/2025. I would now like to turn the conference over to Diantha Duvall.

Operator

Please go ahead.

Speaker 1

Thank you, and welcome to the Curis First Quarter twenty twenty five 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 twenty twenty five 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.

Speaker 1

Joining me on today's call are Jim Dentzer, President and Chief Executive Officer Jonathan Zung, Chief Development Officer and Doctor. Ahmed Hamdi joining us today as our new Chief Medical 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.

Speaker 2

Thanks, Dantha. Good morning everyone and welcome to Curis' first quarter business update call. I'd like to start this quarter's call by welcoming Doctor. Ahmad Hamdi to the Curis executive team. Doctor.

Speaker 2

Hamdi is a well known and respected leader in the industry and brings a wealth of experience as the CMO of Pharmacyclics, founder and CMO of Asserta, and founder and CEO of Vince Rx. Hakman, welcome.

Speaker 3

Thank you, Jim. It's a great pleasure to be here. I'm excited to join the Cureus team at this very critical time to advance emavucertib towards regulatory filings in primary CNS lymphoma in both US and Europe. Also look forward to expand its use beyond primary CNS into additional indications like NHL, AML, and solid tumors. Given my experience in both ibrutinib and calibrutinib, I have a special appreciation for the potential of imavusertib in combination with BTK inhibition in NHL.

Speaker 3

I look forward to working with the team here at Curis to bring novel therapies to patients.

Speaker 2

Thanks, Amit. In addition to strengthening our leadership team with Doctor. Hamdi, we continue to make steady progress in our take aim lymphoma study, which is evaluating emovacertib in combination with ibrutinib in PCNSL patients. As a reminder, the take aim lymphoma study is a single arm study with an ORR endpoint in patients with PCNSL who have progressed on BTKi treatment. And after collaborative discussions with FDA and EMA over the last year, we expect the study to support accelerated submissions in both The U.

Speaker 2

S. And Europe. As of 01/02/2025, the most recent data cutoff date, twenty seven patients with relapsedrefractory PCNSL have been treated with the emavusertib and ibrutinib combination, including seven BTKi naive patients and twenty BTKi experienced patients. Among thirteen of the 20 BTKi experienced patients for whom change in tumor burden data were available, nine patients demonstrated a reduction in tumor burden, including six objective responses, two partial responses, and four complete responses, with three of the four CRs lasting more than six months and one patient who has been in complete remission for almost two years and is still on study. Among six of seven BTKi naive patients for whom change in tumor burden data were available, five patients demonstrated a reduction in tumor burden including five objective responses, four partial responses and one complete response.

Speaker 2

We expect to have additional data from the Take Aim Lymphoma study at ASH later this year. In addition, over the next twelve to eighteen months, we'll be focused on enrolling 30 to 40 additional patients we'll need for the NDA submission and we'd like to see six to eight responses in that dataset. Now let's turn to AML. As you'll recall, at the ASH Conference in December, Doctor. Eric Weiner from Dana Farber presented data for twenty one patients with a FLT3 mutation who had received fewer than three lines of prior therapy and were treated with amivocertib as monotherapy at the RP2D of three hundred milligrams BID.

Speaker 2

These data show a thirty eight percent composite CR rate in the salvage line setting with 10 objective responses in 19 response evaluable patients and seven of the 10 responses reported at the first assessment. To put these data into context, gilteritinib, the leading FLT3 inhibitor in relapsedrefractory AML, was approved with a composite CR rate of twenty one percent in a patient population where only thirteen percent of patients had been previously treated with a FLT3 inhibitor. In the emavucertib study, over eighty percent of the patients had been previously treated with a FLT3 inhibitor. We believe the reason the emavucertib data are so compelling is its novel mechanism of action. It blocks both IRAK4 and FLT3.

Speaker 2

For several years, it has been suggested in the literature that blocking IRAK4 can enable patients to overcome adaptive resistance to FLT3 inhibition. These clinical data clearly support that thesis. Finally, I'd like to provide an update on our progress with the triplet study in frontline AML. As a reminder, we initiated a Phase one study last year of emavusertib as an add on agent to venetoclax and azacitidine in frontline AML. This study is assessing safety and tolerability where emivocertib is added to a patient's Venaza regimen in seven, fourteen, and twenty one day dosing regimens after they have achieved a CR and VENESA but are still positive for minimal residual disease.

Speaker 2

We have successfully completed the seven day dosing cohort and enrollment of the fourteen day cohort is currently ongoing. As you can see, we've had a very exciting and productive quarter. We look forward to providing additional updates as the year progresses. With that, I'll turn the call back to Diantha for a financial update. Diantha?

Speaker 1

Thank you, Jim. Cureus reported a net loss of $10,600,000 or $1.25 per share for the first quarter of twenty twenty five compared to a net loss of $11,900,000 or $2.05 per share for the same period in 2024. Research and development expenses were $8,500,000 for the first quarter of twenty twenty five as compared to $9,600,000 for the same period in 2024. The decrease was primarily attributable to lower employee related costs. General and administrative expenses were $4,000,000 for the first quarter of twenty twenty five as compared to $4,900,000 for the same period in 2024.

Speaker 1

The decrease was primarily attributable to lower employee related costs, professional, legal and consulting costs. In March we completed a registered direct financing and concurrent private placement with net proceeds of approximately $8,800,000 Cures' cash and cash equivalents totaled $20,300,000 as of 03/31/2025, and the company had approximately 10,500,000.0 shares of common stock outstanding. Curis expects its existing cash and cash equivalents will enable its planned operations into the fourth quarter of twenty twenty five. With that, I'd like to open the call up for questions. Operator?

Operator

Thank you so much. Ladies and gentlemen, we'll now begin the question and answer session. Should you wish to remove your hand from the question and answer process, please press star followed by 2. If you're using a speakerphone, please lift the handset before pressing any keys. One moment for your first question.

Operator

And your first question comes from Lee Watts with Cantor. Please go ahead.

Speaker 1

Hey, good morning, guys. Wanted to welcome Doctor. Hendi to the team. Maybe just a couple of questions from us. I guess big picture on your positioning of lymphoma versus AML, just given you have a relatively straightforward path to approval in CNS lymphoma, you might need a large study in frontline AML.

Speaker 1

I guess the question is, number one, how much data do you want to generate in frontline AML to either move forward or maybe pause and focus on the lymphoma opportunity? And the second is what are the things you're doing or could be doing to potentially accelerate the enrollment of the lymphoma study?

Speaker 2

Thank you, Lee, it's Jim. So let me address this briefly, lymphoma versus AML, and then I'll ask Doctor. Zung to talk about the things we're doing on enrollment. So in lymphoma versus AML, we are moving ahead with both simultaneously. Now more resources, of course, are dedicated to the PCNSL study, it's farther along, many more sites, many more patients, of course.

Speaker 2

So our focus in lymphoma is in primary CNS lymphoma and enrolling as many patients as we can towards that thirty to forty target we need to get to NDA submission. On the AML side, the spend is a little lighter because it's earlier stage, but we're focused on our frontline study getting through that safety study. So we're trying to evaluate, as you know, amivasertib in combination with Venaza in the frontline setting. And while we think that has a long term very strong potential, in the short term, our focus is really just enrolling a small number of patients to clear those initial regimens for safety. So it's a relatively small use of our resources, but it's absolutely just as strong a focus for us as the primary CNS lymphoma side.

Speaker 2

And with that, maybe Jonathan, if you'd like to chime in on the enrollment.

Speaker 4

Sure. In terms of the enrollment in the lymphoma program, we've got 37 sites that are currently open. We're at the major centers of excellence in The U. S, Europe and Israel where the patients are seen and treated. We have regular site engagement outreaches with the investigators and the coordinators.

Speaker 4

So we're doing everything that's normally done in a clinical trial to sort of drive engagement to result in enrollment.

Speaker 3

Good morning Lee, this is Ahmed. Obviously there's quite a bit of thinking that's going on right now as far as the NHL indications and the AML. So there's more discussions that are going be coming down the road on how do we prioritize and when do we prioritize. Obviously we'll keep everybody posted.

Speaker 2

Yeah, and as you can imagine Lee, obviously we're all thrilled to get Doctor. Hendi here on board as part of the team. And as we not just push ahead aggressively towards PCNSL, but look to expand across NHL and AML to make the most of this drug wherever it provides utility, Obviously, we're very eager to the team and really look forward to our progress. Thank you.

Operator

Thank you, guys. Thank you. Your next question comes from Kripa Devarakonda with Truist. Please go ahead.

Speaker 5

Hey, guys. Thank you so much for taking my question, and congratulations on bringing Doctor. Handy aboard. So, a couple of questions. One for the lymphoma.

Speaker 5

You noted you have 37 sites open. I think previously you had mentioned 30. Just wondering if is the final or you're planning to add more sites and are you still on track to complete enrollment in the timeframe that you had mentioned? I think last time you had said twelve to eighteen months. And have you had any additional conversations with the FDA?

Speaker 5

Just given all the changes with the FDA, just was wondering if there's any concern that the agreement that you came to with the FDA will continue to be respected with all the changes that are happening? Thank you.

Speaker 4

So Jim, this is Jonathan. So on the enrollment side, there are no real changes there. We're constantly looking at the sites that we have opened. We opened, as we had mentioned in previous calls, additional sites last year. So that's where we are.

Speaker 2

Yeah, on the FDA side, Crippa, I don't think we have any concerns at all that there'll be a change. I think we're grateful to be blunt that we were able to get to the FDA to get the collaboration that we needed last quarter before this current turmoil started. Worry about the industry and about companies who have to reach out to gain similar effort from the FDA in this climate. But I think for Curis' perspective, we were very fortunate in our timing. We're grateful to have their support and we're pushing ahead.

Speaker 2

So yeah, we share your concern for the industry as a whole, but I think from Curis' perspective, we're pleased about where we are.

Speaker 5

Great, thank you so much for the color.

Operator

Your next question comes from Sumeet Roy with Jones Research. Please go ahead.

Speaker 6

Hi. Thank you for taking my question. This is Dania for Sumeet Roy. I have a question about your ASCO presentation. Can you give any color on what type of mutations might affect responses?

Speaker 6

And I have another question for the AML. Are there any updates on potential development steps for EMA in relapsedrefractory AML? Thank you.

Speaker 2

Yeah, so why don't I take the first one and then actually I'll ask Jonathan to chime in on the second one. So on the first one I think it's little too early to talk about mutations and their impact. I think the primary impact that we see with emivosertib is really driven by the mechanism of action more broadly. So as we know, the way to treat NHL is to down regulate the overactivity of NF kappa B. Historically, at least for the last ten years paved by a pharmacyclics, the way to do that is with a BTK inhibitor, it blocks the BCR pathway, which is one of the two pathways that drives NF kappa B.

Speaker 2

We have the only drug that blocks the other pathway, the TLR pathway. And our thesis, which panned out in the lab and we now see in the clinical data, it's panning out as well, is that when you block both pathways that are driving NF kappa B, you can maximize the down regulation of NF kappa B activity and that's what's driving the benefit to patients. So it's less about any particular genetic mutation and it's more about blocking the fundamental drivers of that oncologic activity. And Jonathan, maybe if you could chime in on the second one on Yeah,

Speaker 4

on the AML development side obviously once we complete the ongoing triplet study, the safety study along with the data that we've presented Eric Weiner, Dana Farber presented, we'll come back and talk about what forward plans are on the AML side, whether it's frontline, relapsedrefractory and or both. Yes.

Speaker 2

And I would close also in saying one of the things that should be very clear to everyone on the call, certainly very clear to us on the team, is one of the biggest advantages of having Doctor. Handy join the team is now that we've got a solid path on primary CNS lymphoma, we're looking to expand across NHL to everywhere where BTK inhibitors provide benefit. Because if a BTK inhibitor provides benefit in an NHL indication, whether it's PCNSL, CRL, Waldenstrom's, any of the indications where a BTK inhibitor gets used, that's going to be an opportunity where blocking the second pathway could provide benefit. It's exactly what we see in our first indications, it's exactly what we saw in the lab, and it's precisely why we've asked Doctor. Hamdi to come on board.

Speaker 2

So I look forward to reporting out that progress.

Speaker 6

Okay, great, thank you.

Operator

Thank you so much. And at this time, there are no further questions. I would now like to pass the call over to Jim Dentzer for closing remarks.

Speaker 2

Thank you, operator, and thank you everyone for joining today's call. And as always, thank you to the patients and families participating in our clinical trials, to our team at Curis for their hard work and commitment, and to our partners at Aurigene, the NCI, and the academic community for their ongoing collaboration and support. We look forward to updating you again soon. Operator?

Operator

Ladies and gentlemen, this concludes today's conference call. Thank you so much for your participation. You may now disconnect.

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Key Takeaways

  • Curis strengthened its executive team by appointing Dr. Ahmed Hamdi as Chief Medical Officer to advance emavucertib filings in primary CNS lymphoma and explore additional indications like NHL, AML, and solid tumors.
  • In the Take Aim Lymphoma study of emavucertib plus ibrutinib in relapsed/refractory PCNSL, 9 of 13 BTKi-experienced patients showed tumor burden reduction (6 responses including 4 CRs) and 5 of 6 BTKi-naive patients responded, supporting plans for accelerated U.S. and European submissions.
  • A monotherapy study of emavucertib in FLT3-mutated relapsed/refractory AML demonstrated a 38% composite CR rate at the RP2D, outperforming gilteritinib’s 21% rate despite over 80% of patients having prior FLT3 inhibitor exposure.
  • The frontline AML triplet study adding emavucertib to venetoclax and azacitidine has completed the 7-day dosing cohort and is actively enrolling the 14-day cohort to assess safety and tolerability post-CR for MRD-positive patients.
  • For Q1 2025, Curis reported a net loss of $10.6 M ($1.25/share) versus $11.9 M in Q1 2024, reduced R&D and G&A expenses, net proceeds of $8.8 M from financing, and a cash runway into Q4 2025 with $20.3 M on hand.
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Earnings Conference Call
Curis Q1 2025
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