Curis Q4 2024 Earnings Report

Curis EPS Results

• Actual EPS: -$1.25
• Consensus EPS: -$1.36
• Beat/Miss: Beat by +$0.11
• One Year Ago EPS: N/A

Curis Revenue Results

• Actual Revenue: $2.70 million
• Expected Revenue: $2.04 million
• Beat/Miss: Beat by +$660.00 thousand
• YoY Revenue Growth: N/A

Curis Announcement Details

• Quarter: Q4 2024
• Date: 3/31/2025
• Time: Before Market Opens
• Conference Call Date: Monday, March 31, 2025
• Conference Call Time: 8:30AM ET

Curis (NASDAQ:CRIS), a biotechnology company, engages in the discovery and development of drug candidates for the treatment of human cancers in the United States. Its clinical stage drug candidates include Emavusertib, an oral small molecule IRAK4 kinase inhibitor, which is in a Phase 1/2 open-label, single arm expansion trial in patients with relapsed or refractory, or R/R, AML and high-risk myelodysplastic syndromes. The company's pipeline also includes Fimepinostat, an oral dual inhibitor of HDAC and PI3K enzymes for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma; CA-170, an oral, small molecule antagonist designated as CA-170 that selectively targets PD-L1 and VISTA; and CA-327, an oral, small molecule, TIM3/PD-L1, which is a molecule antagonist of PD-L1 and TIM3. It has collaboration agreement with Genentech Inc., or Genentech and F. Hoffmann-La Roche Ltd, or Roche, for the commercialization of Erivedge, an orally-administered small molecule hedgehog signaling pathway antagonist for the treatment of advanced basal cell carcinoma, or BCC; Aurigene Discovery Technologies Limited for the discovery, development, and commercialization of small molecule compounds in the areas of immuno-oncology and precision oncology; and also licensed four programs under the Aurigene collaboration, including emavusertib. Curis, Inc. was incorporated in 2000 and is headquartered in Lexington, Massachusetts.

Curis Q4 2024 Earnings Call Transcript

Presentation

[Operator]

Good morning, and welcome to Curisys Fourth Quarter twenty twenty four Business Update Call. All participants will be in listen only mode. Call. After the company's prepared remarks, all participants will have an opportunity to ask questions. Please note this event is being recorded.

[Operator]

I would now like to turn the conference over to Deonta Duval, Chorus's Chief Financial Officer. Deonta, please go ahead.

[Diantha Duvall, Chief Financial Officer at Curis Inc]

Thank you, and welcome to Curis' fourth quarter twenty twenty four 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 fourth quarter twenty twenty four 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.

[Diantha Duvall, Chief Financial Officer at Curis Inc]

Joining me on today's call are Jim Denzer, President and Chief Executive Officer and Jonathan Zohn, 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.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Thank you, Diantha. Good morning, everyone, and welcome to Curis' fourth quarter business update call. We made great progress this quarter in both NHL and AML. Let's start with our TAKAIM lymphoma study, which is evaluating emavucertib in combination with ibrutinib in PCNSL. Before we discuss the clinical data, I'd like to highlight the encouraging feedback we received from the EMA and FDA on the potential for conditional marketing authorization in Europe and accelerated approval in The U.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

S. As a reminder, we engaged both agencies about the potential for accelerated filings after the initial early data from PCNSL patients treated with emabucertib in combination with ibrutinib last year. We met with the agencies in the second half of twenty twenty four and are pleased to announce that both agencies reviewed and provided feedback on our proposed plans for the potential for an accelerated approval pathway based on our ongoing TAKAIM lymphoma study. As a reminder, the study is a single arm open label study being conducted in The U. S, EU and Israel using ORR as the primary endpoint.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Both agencies agreed that patients already enrolled in the trial can be used in the submission as long as they meet the same inclusion exclusion criteria. They also provided helpful guidance on additional information such as contribution of effect to be included as part of the submission and initial thoughts on the design of our confirmatory study. In short, the discussions were very productive. The development timeline for emabucertib just got accelerated. Our current Phase III study is now registrational for both The U.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

S. And Europe. Obviously, this is the outcome we were hoping for. With over 30 clinical sites now open for enrollment, our goal is to complete enrollment in the next twelve to eighteen months. With that, let's turn to the clinical data.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

As a reminder, we're testing the emavucertib ibrutinib combination in two distinct PCNSL populations, BTKI naive patients and BTKI experienced patients. The thesis for the emobasertib ibrutinib combination supported by both preclinical data and clinical data is that blocking both of the pathways driving disease in NHL, blocking the TLR pathway with emabucertib and blocking the BCR pathway with ibrutinib maximizes down regulation of NF kappa B and can enable patients to achieve an objective response even if they've been previously treated with a BTK inhibitor and progress on that treatment. In our press release this morning, we summarized the clinical update for twenty seven relapsedrefractory PCNSL patients in our TAKAYANE lymphoma study, including 20 BTKI experienced patients and seven BTKI naive patients. Among the 20 BTKI experienced patients, change in tumor burden data were available for thirteen of them at the cutoff date. Nine of these 13 patients demonstrated a reduction in tumor burden, including six objective responses, four CRs and two PRs with three of the four CRs lasting more than six months.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Among the seven BTKI naive patients, change in tumor burden data were available for six of them at the cutoff date. Five of these six patients demonstrated a reduction in tumor burden, including five objective responses, one CR and four PRs. In summary, we're very encouraged by both the clinical data and the clarity from EMA and FDA on our proposed registrational plans. Over the next twelve to eighteen months, we'll be focused on enrolling 30 to 40 additional patients to support a filing for accelerated approval. Finally, to cap off our progress in NHL this quarter, we're pleased to announce that emabucertib has been granted orphan drug designation for primary CNS lymphoma in both The U.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

S. And in Europe. With that, let's turn to AML. 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 emoversertib as monotherapy at the RP2D of three hundred milligrams BID.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

These data show a thirty eight percent composite CR rate in the salvage line setting with 10 objective responses in 19 response evaluable patients, six full CRs, two CRs with partial or incomplete hematological recovery and two morphologic leukemia free state responses. We were especially encouraged to see that these responses were achieved rapidly with seven of 10 responses reported at the first assessment. To put these data in context, we know that FLT3 patients in the relapsed refractory setting typically receive gilteritinib, a FLT3 inhibitor which was approved with a composite CR rate of twenty one percent. And it's important to remember that this twenty one percent rate was in an ideal population of patients predominantly naive to FLT3 inhibition. The emabucertib study on the other hand was in salvage line patients.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Over eighty percent of the patients on emavucertib had already been treated with a FLT3 inhibitor and failed. We believe the reason emagocertib data were so compelling is its novel mechanism of action. It blocks both IRAG4 and FLT3. For several years, it has been suggested in the literature that blocking IRAC4 can enable patients to overcome adaptive resistance to FLT3 inhibition. These clinical data clearly support that thesis.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Finally, I'd like to provide an update on our progress with the triplet study in frontline AML. As a reminder, in 2024, we initiated a Phase one study of emabucertib as an add on agent to venetoclax and azacitidine in frontline AML. This study is assessing safety and tolerability where emobasertib is added to a patient's VENAZA regimen in seven, fourteen and twenty one day dosing regimens after they have achieved a CR on VENAZA and while they remain positive for minimal residual disease. We have successfully completed the seven day cohort and enrollment of the fourteen day cohort is currently ongoing. In short, we had a very productive 2024 and have entered 2025 with positive momentum.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

We look forward to providing you with additional updates as the year progresses. With that, I'll turn the call over to Diantha for the financial update. Diantha?

[Diantha Duvall, Chief Financial Officer at Curis Inc]

Thank you, Jim. Cures reported a net loss of $9,600,000 or $1.25 per share for the fourth quarter of twenty twenty four compared to a net loss of $117,000,000 or $2.03 per share for the same period in 2023. Cures reported a net loss of $43,400,000 or $6 per share for the twelve months ended 12/31/2024 compared to a net loss of $47,400,000 or $8.96 per share for the same period in 2023. Research and development expenses were $9,000,000 for the fourth quarter of twenty twenty four compared to $10,000,000 for the same period in 2023. The decrease was primarily attributable to lower clinical, research, consulting and employee related costs, partially offset by higher manufacturing costs.

[Diantha Duvall, Chief Financial Officer at Curis Inc]

R and D expenses were $38,600,000 for the twelve months ended 12/31/2024, compared to thirty nine point five million dollars for the same period in 2023. General and administrative expenses were $3,400,000 for the fourth quarter of twenty twenty four compared to $4,900,000 for the same period in 2023. The decrease was primarily attributable to lower legal, facility consulting and employee related costs. G and A expenses were $16,800,000 for the twelve months ended 12/31/2024, compared to $18,600,000 for the same period in 2023. In October, we completed a registered direct offering and concurrent private placement with net proceeds of approximately $10,800,000 On 03/28/2025, we priced a registered direct offering and concurrent private placement of common stock pre funded warrants and warrants with gross proceeds of approximately $10,000,000 The impact of these two offerings has extended our cash runway into the fourth quarter of twenty twenty five.

[Diantha Duvall, Chief Financial Officer at Curis Inc]

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

[Operator]

Thank you. With that, our first question comes from the line of Pripa de Veracrundo with Truett Securities. Please go ahead.

[Nicole Germino, Stock Analyst at Truist Securities]

Hi, good morning. This is Nicole on for Pripa. Can you just talk a little bit more about cash flow and how we should be thinking about expenses going forward? Any additional cost modulations we should be considering as we update our models?

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Yes. Actually, Dantha, why don't you walk through that?

[Diantha Duvall, Chief Financial Officer at Curis Inc]

Absolutely. So we've previously guided that our cash our burn is about $10,000,000 a quarter and that continues to be the case. So again, these the proceeds from these two offerings that we did fourth quarter of last year and first quarter of this year does extend our cash runway from mid-twenty four to the fourth quarter of twenty twenty five.

[Nicole Germino, Stock Analyst at Truist Securities]

Okay, great. And one quick follow-up. Can you just talk a little bit about any potential inbound interest from partners? In this environment, are there any additional hurdles for partnerships other than fitting into the landscape?

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Sure. Well, as you can imagine, given the utility that we've seen so far in NHL and AML, we're on radar screens. I would say just as a matter of course, we expect that we will be continuing to have discussions on how to best move our program forward. And at some point, I suspect that's going to involve partnering with one of the major players in either the NHL or AML space. Stay tuned.

[Operator]

Thanks so much. And your next question comes from the line of Sean McCutchen with Raymond James. Please go ahead.

[Sean McCutcheon, Vice President - Biotechnology Equity Research at Raymond James Financial]

Hey guys, thanks for the questions. Can you remind us how many primary central system nervous system lymphoma patients have been given the one hundred milligram BID dose of emilocertib to date, either as monotherapy or in combination with ibrutinib and perhaps walk us through the necessary steps to meet the FDA's requirement on the individual component contributions. And obviously based on your commentary, it's a review issue for the number of patients you'll need, but would you anticipate the number at a go forward dose being roughly in line with what the EMA expects?

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Yes. Actually, Jonathan, you're probably the best to address that one.

[Jonathan Zung, Chief Development Officer at Curis Inc]

Sure. So to date, we've dosed 13 patients at one hundred milligrams. Those patients have been dosed in Part B of the study. Remind me of your second part of the question?

[Sean McCutcheon, Vice President - Biotechnology Equity Research at Raymond James Financial]

Second part was just the steps you'll need in order to meet the FDA's requirement on the individual component contributions and then roughly the number of patients you'd expect to need within The U. S. At a go forward dose?

[Jonathan Zung, Chief Development Officer at Curis Inc]

Yes. So we would expect that The U. S. And Europe will be using similar data. And when we think about the dose selection, we'll be able to make that after about nine patients that have been dosed on 100 and two hundred.

[Sean McCutcheon, Vice President - Biotechnology Equity Research at Raymond James Financial]

Thanks.

[Operator]

And your next question comes from the line of Lee Watsak with Cantor Fitzgerald. Please go ahead.

[Li Watsek, Director at Cantor Fitzgerald]

Yes. Thank you. Good morning. Thank you so much for the update and taking our question. We were wondering if you could give us a little more color on what the EMA might expect in terms of compelling and consistent data in terms of the response rates that you have mentioned.

[Li Watsek, Director at Cantor Fitzgerald]

Thank you.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Sure. Why don't I start on that and then I'll ask Jonathan to opine as well. So I think what both agencies clearly I think were so supportive of our efforts to bring a treatment to primary CNS lymphoma based on the data that we've seen to date and the data that we've seen to date are very compelling. Obviously, we would be hoping that as we complete enrollment in the study that the data remain consistent and that the compelling results that we've seen to date hold as we finish out enrollment in that study. Jonathan, would you like to add your thoughts?

[Jonathan Zung, Chief Development Officer at Curis Inc]

Yes. The only thing I would add is both agencies clearly acknowledge there are no approved treatments in this space. And I think that's why we had favorable discussions with them. And as Jim mentioned, where the response rate is today, as long as we are probably north of twenty five percent, we'll OR we should have positive momentum with both agencies.

[Li Watsek, Director at Cantor Fitzgerald]

Great. Thank you very much.

[Operator]

Your next question comes from the line of Ed White with H. C. Wainwright. Please go ahead.

[Edward White, Managing Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC]

Hi. Thanks for taking my questions. You just had mentioned the agency is looking for north of 25% ORR. Is this a bit of a change? I think in the past you've mentioned that they're looking for a CR rate above 20%.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

No, let me add to that and then I'll ask Jonathan to opine as well. I think what we're really looking to do is to ensure that we've got data that are consistent with the past and of course give us a 95% confidence interval that we can beat a null hypothesis of 10%. So 20% clearly does that. We're much higher than that now. I think if we end up somewhere in a 25% range where we've got a lot of cushion over the 95% confidence interval.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

So I think really that's all we were saying that we're going at the salvage line setting in these patients simply because there really aren't good options for these patients. So that if we continue to see the kind of efficacy that we've seen to date, we should be in a good position. Jonathan, do you want to add your thoughts on that?

[Jonathan Zung, Chief Development Officer at Curis Inc]

Yes. Nothing to add to that, Jim. That's exactly it.

[Edward White, Managing Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC]

And Jim, how

[Edward White, Managing Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC]

should we be thinking about taking leukemia? It seems like you're focusing on PC, NSL patients. Should we expect to see more enrollment in leukemia study? And also should we expect to see more data later this year?

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Yes. So I want to be more cautious about what kind of data in leukemia that we're going to see later this year. I think the two places where everybody is excited is, of course, on the triplet study and then in potentially a monotherapy study in FLT3. So on the triplet study, as we mentioned in the release and in my comments, we've completed enrollment in the seven day cohort, looks safe and well tolerated. And our goal would be of course to do the same for the fourteen and twenty one day studies.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Once we've established safety and that's the critical item in that study, make sure we can show that adding m of assertive to current standard of care is safe and tolerable. Well then we would move of course to start dosing with all three drugs starting day one. And at that point, we're looking for efficacy. We're looking to see whether adding EMA does the same thing in the clinic that it did in the lab. And that is that it added efficacy to the VENAZO doublet.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

So that would be one thing that we would look to move toward in leukemia. And then on the other side, of course, there's a lot of interest among the KOLs for a monotherapy extension into the FLT3 population. It looks as though at this point, the data we have suggest emobasertib is a best in class FLT3 drug as a monotherapy, which makes sense, right. It's the only drug that blocks IREQ4 and FLT3. So it should be the best in class.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

We would need to run another study, a pivotal study to prove that and to gain approval, but there's a lot of enthusiasm for that path as well. I would look forward hopefully as the year progresses and we make progress in getting those studies initiated, we'll have a better sense of timelines and can be able to set for you what data we would expect when. Does that make sense?

[Edward White, Managing Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC]

Yes. Thanks, Jim.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Great. Thanks, Ed.

[Operator]

Ladies and gentlemen, this concludes our question and answer session. I would like to turn the conference back to the company's President and CEO, James Denzer, for any closing remarks.

[James Dentzer, President and Chief Executive Officer at Curis Inc]

Thank you, operator. And thank you everyone for joining us on today's call. And especially thank you to our teammates at Curis for their hard work and for our partners, especially at Origine and the NCI and at academic sites helping us develop this important drug. We appreciate your time today and we look forward to providing updates in the near future. Operator?

[Operator]

Thank you. And ladies and gentlemen, this concludes today's conference call. Thank you all for joining. You may now disconnect.

Participants

Executives

• Diantha Duvall, Chief Financial Officer
• James Dentzer, President and Chief Executive Officer
• Jonathan Zung, Chief Development Officer

Analysts

• Nicole Germino, Stock Analyst at Truist Securities
• Sean McCutcheon, Vice President - Biotechnology Equity Research at Raymond James Financial
• Li Watsek, Director at Cantor Fitzgerald
• Edward White, Managing Director, Senior Biotechnology Analyst at H.C. Wainwright & Co., LLC