Curis Q3 2023 Earnings Call Transcript

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November 2, 2023

There are 5 speakers on the call.

Operator

The conference is now being recorded.

Speaker 1

Please note that this event is being recorded. I would now like to turn the conference over to Diantha Duvall, Curis' Chief Financial Officer. Diantha, please go ahead.

Operator

Thank you, and welcome to Curis' Q3 2023 business update call. Before we begin, I'd like to encourage everyone to go to the Investors section of our website at www.curis.com to find our Q3 2023 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.

Operator

Joining me on today's call are Jim Dentzer, President and Chief Executive Officer and Jonathan Zung, our Chief Development Officer. We will also be available for a question and answer period at the end of our call. I'd now like to turn the call over to Jim.

Speaker 2

Thank you, Dantha. Good morning, everyone, and welcome to Curis' 3rd quarter business update call. This quarter marked a key inflection point for the company and for patients as we were able to return our focus to clinical enrollment in our TAKAYAME leukemia and TAKAYAME lymphoma studies with the removal of the partial clinical hold. Later this morning, abstracts for the 65th ASH Annual Meeting will be unveiled and we are pleased to have several abstracts under consideration. At ASH, we expect to provide an update from our TAKE AIM lymphoma study, including our first look at proof of concept data for patients with primary CNS lymphoma, a rare form of extranodal non Hodgkin lymphoma for which there are limited treatment options.

Speaker 2

In the TAKING leukemia study, We have reopened our clinical sites and are working with them to identify and enroll new patients. As a reminder, The taking leukemia study is a monotherapy study targeting patients with relapsed or refractory AML with either a FLT3 or spliceosome mutation. Enrollment of new patients has begun and we expect to have our first look at data from these patients in the first half of twenty twenty four. Lastly, we are working with clinical sites and regulatory authorities on advancing a new triplet study of emavusertib in combination with azacitidine and venetoclax in AML. This study is intended to evaluate safety as well as emilversertib's ability to enhance the effectiveness of azacitidine and venetoclax by studying AML patients who are responding to azacitidine and venetoclax treatment, but still have minimal residual disease or MRD.

Speaker 2

Our hope is that with the addition of emilucertib to their treatment regimen, we can help these patients convert from MRD positive status to MRD negative. We expect to initiate this study in the 4th quarter and see initial data in the second half of next year. In short, we're making great progress in advancing the potential of emabusertib as a monotherapy, as a doublet therapy combining with Ibrutinib and as a triplet therapy in combination with azacitidine and venetoclax, all of which should have data over the coming 4 quarters. We look forward to providing those updates. With that, I'll turn the call back over to Diantha to review our financial results for the quarter.

Speaker 2

Diantha?

Operator

Thank you, Jim. For the Q3 of 2023, Curis reported a net loss of $12,200,000 or 2 $300,000 or $2.83 per share for the same period in 2022. Curis reported a net loss of $35,700,000 Or $6.96 per share for the 9 months ended September 30, 2023 as compared to a net loss of 45,300,000 or $9.82 per share for the same period in 2022. Revenues for the 3rd quarters of 20 3 and 2022 were both $2,800,000 Revenues for both periods consist of royalty revenues from Genentech, Genentech and Roche's sales of Erivedge. Revenues for the 9 months ended September 30, 2023, 2022 were both $7,300,000 Research and development expenses were $10,400,000 for the Q3 of 2023 as compared to $10,800,000 for the same period in 2022.

Operator

The decrease in research and development expenses for the quarter is primarily attributable to lower employee related costs due to a reduction in headcount, partially offset by increased clinical costs. Research and development expenses were $29,500,000 for the 9 months ended September 30, 2023, as compared to $34,600,000 for the same period in 2022. General and administrative expenses were 4 $8,000,000 for the Q3 of 2023 as compared to $4,600,000 for the same period in 2022. The increase was primarily attributable to higher professional, legal and consulting services costs. General and administrative expenses were $13,800,000 for the 9 months ended September 30, 2023 as compared to $15,300,000 for the same period in 2022.

Operator

Other income net was $200,000 for the Q3 of 2023 as compared to other expense net of $700,000 for the same period in 2022. Other income and expense net primarily consists of interest income partially offset by non cash expense related sale of future royalties. Other income net was $400,000 for the 9 months ended September 30, 2023 Compared to other expense net of $2,500,000 for the same period in 2022. As of September 30, 2023, Curis' cash, cash equivalents and investments totaled $68,500,000 and there were approximately 5,900,000 shares of On the stock outstanding. We continue to be in a strong cash position and expect that our existing cash, cash equivalents and investments should enable us to maintain our planned operations into 2025.

Operator

With that, I'd like to open the call for questions.

Speaker 1

Your first question comes from Yale Jen from Laidlaw and Company. Yale, please go ahead.

Speaker 3

Good morning and thanks for taking the questions and congrats on the progress. Two questions here. The first question is that in terms of the ASH abstract you intend to present, Could you give us a little bit color, you mentioned there's more than 1. So what's the general context of that? Then I have a follow-up.

Speaker 2

Yes. So thank you, Yale. I appreciate that. So we

Speaker 1

are going to defer most

Speaker 2

of the comments about the ASH abstract until the abstracts go live. However, what I would say is that we have got leukemia and lymphoma ongoing. The leukemia study Really got started or restarted in July with the enrollment of new patients. So those data are really a 2024 story, not an ASH story. Lymphoma is really going to be the new data that are coming at ASH.

Speaker 2

And as we've talked about before, We have in the past looked at monotherapy and combination therapy. We've established our dose And we've targeted the indication of primary CNS lymphoma as the ideal place for us to go. The reason we selected primary CNS Was as you recall, 1st, it's an orphan indication within lymphoma. So that means a relatively small number of patients would be needed on the regulatory path. 2nd, there is a very clear unmet need.

Speaker 2

There is an Established benchmark for what Ibrutinib looks like in monotherapy in primary CNS lymphoma. Ibrutinib attained a 19% CR rate. And then 3rd, it really is going to Establish what I hope to be a nice opportunity for us to demonstrate first whether we can be an additive Benefit, can we increase the CR rate by adding our drug to Ibrutinib? But also can we get CRs in patients who have progressed on BTK treatment. Can they be resensitized?

Speaker 2

That has always been the hypothesis for emavucertib and IRAC4 inhibition, this will be the first time we can see data to see whether or not that's possible. So that would be my expectation for reviewing the data at ASH. Leukemia is a 2024 story. The ASH story is going to be lymphoma.

Speaker 3

Okay, great. That's helpful. And the second question here is that you have mentioned earlier that Before that, high risk and MDS development Well, it depends on what you see, what the sort of standard of care potentially could be established. So you will set up the footing for doing that. And what's your current thoughts in terms of that aspect?

Speaker 2

No, that's exactly right. So and by standard of care, As you know, the standard of care in AML is the azacitidine venetoclax doublet. Today, as we stand, the standard of Karen MDS is azacitidine monotherapy. The azacitidine venetoclax study is still pending. That's the VIRONA study and those results presumably are imminent.

Speaker 2

So we are waiting to see of course If that study is positive or negative, if that study is positive and the doublet is also the standard of care in MDS, we'll want to Proceed with a triplet. If on the other hand it's negative and azacitidine remains as monotherapy the standard of care, then we would look to proceed with a doublet. Is that helpful?

Speaker 3

Absolutely. That's very, very helpful. And maybe Any timeline you can sort of speculate at this point?

Speaker 2

We don't run that study. So unfortunately, no. I mean, I think what the broader world is expecting is that it's sometime over the next few months, whether that's ASH or sometime in early 2024, Of course, we don't know any more than you do, but we are eagerly awaiting the outcome of those data.

Speaker 3

Okay, great. That's very helpful. And again, congrats on the progress and look forward to see things at Edge.

Speaker 1

Your next question comes from Leigh Whatek from Cantor Fitzgerald. Lee, please go ahead.

Speaker 4

Hey, good morning. Thanks for taking our questions. Jim, maybe Can you just frame the expectations for us a little bit for the data update in first half of next year, Particularly in AML and MDS, what the bar will be?

Speaker 2

Yes. So In AML and MDS, it's going to be separate, right? So we are proceeding with monotherapy in patients in the relapsed refractory setting for FLT3 and spliceosome patients. And MDS as Yale asked about, we are really awaiting news of the VIRONA study to make sure we understand the path forward. In FLT3 And spliceosome, the benchmarks are pretty clear.

Speaker 2

FLT3 CR8 with gilteritinib and gilteritinib as you know is The market leader for FLT3 inhibitors is 12%. So of course, we would look To want to improve on that. Their CRH rate was 22.6% and of course we would want to improve on that. In spliceosome patients, it's not clear that there are any treatments capable of getting a CR rate. As far as I know, there's never been anything published.

Speaker 2

The only data in the literature addressing spliceosome patients is that they have the worst of the worst Prognosis. So as you know, in relapsedrefractory AML, the survival is unfortunately quite poor. Median survival in studies ranges from 2 to 4 months. And what we understand From the literature is that the lower end of that range is for the splice of some patients. But as far as we know, nobody has ever demonstrated you can get a response.

Speaker 2

So in FLT3, What we're looking to do is can we improve upon FLT3 inhibitors as a class with our FLT3 IRAK4 Targeting molecule, emoVosertib and that would be beating a 12% CR rate or a 22.6% CRH rate. And in spliceosome patients, it would be anything that would be greater than 0 that presumably something north of 10 would be very exciting in that setting. Is that helpful?

Speaker 4

Okay. Yes. And I have another question for the triplet. Do you think you need to do more dose work for the combination? And also do you anticipate any drug drug Interaction with the triplet regimen?

Speaker 2

Excellent question. So the answer to the second one of Do we expect any DDI drug drug interaction? I'd say we don't expect it based on the work we've done in the lab and the clinical work we've done to date. We don't See that there is an overlapping safety profile. That said, of course, that's why you run the studies to see whether or not that stays consistent.

Speaker 2

In terms of our expectation, could you remind me where you were headed with that first part of the question In the triplet?

Speaker 4

Do you need to do more dose work?

Speaker 2

That's right. So the answer to that is yes. I mean, our first foray into the triplet study, we're going to be evaluating both safety and efficacy. So we think we know the right dose. We certainly know the right dose for monotherapy.

Speaker 2

We think we have the right dose in Combination with Ibrutinib and venetoclax, but this will be the first time we've studied the triplet in the clinic of Aza and VEN And Emma. So I think based on the results of those, one of the things we're going to want to see is can we determine the appropriate Dosing regimen for emulsertib in that setting. Any other questions, Leigh?

Speaker 4

No, that's great. Thank you.

Speaker 2

Excellent. Thank you.

Speaker 1

Your next question comes from Dane Leone from

Speaker 2

Raymond

Speaker 3

James.

Speaker 1

He disconnected from the line. Your next question comes from A. J. Rashid from Columbia Eagle. A.

Speaker 1

J, please go ahead.

Speaker 2

On the Overland dispute? That last one broke up. I'm sorry about that. Are there any other questions in the queue?

Speaker 1

Okay. It appears there are no further questions. So, this concludes our question and answer session. I'd like to turn the conference back over to the company's President and Chief Executive Officer, James Fenzer, for any closing remarks.

Speaker 2

Thank you, Colin, and thank you everyone for joining today's call. As always, thank you to the patients and families participating in our clinical trials, to our team at Curis for their tireless commitment and to our partners at Aurigene and the NCI for their ongoing help and support. We look forward to updating you again soon. Colin?

Speaker 1

Thank you. Ladies and gentlemen, this concludes your conference

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Key Takeaways

  • Removal of the partial clinical hold on emavusertib allowed Curis to resume enrollment in its TAKAYAME leukemia and lymphoma studies, with lymphoma proof-of-concept data (including primary CNS lymphoma) expected at ASH and leukemia data in H1 2024.
  • Curis plans to initiate a triplet study of emavusertib + azacitidine + venetoclax in AML patients with minimal residual disease in Q4 2023, with initial safety and efficacy readouts anticipated in H2 2024.
  • The company is advancing emavusertib as monotherapy, in a doublet with ibrutinib for primary CNS lymphoma, and as the prospective triplet in AML—all of which should generate data over the next four quarters.
  • For Q3 2023, Curis reported a net loss of $12.2 million ($2.83 per share) and ended the period with approximately $68.5 million in cash, cash equivalents and investments, which is expected to fund operations into 2025.
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Earnings Conference Call
Curis Q3 2023
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