Q3 2023 Curis Inc Earnings Call
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Okay.
Two please note that this event is being recorded I would now like to turn the conference over to Diantha Duvall curious as Chief Financial Officer Diantha. Please go ahead.
Hmm.
Okay.
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Thank you and welcome to curious as third quarter 2023 business update call before we begin I would like to encourage everyone to go to the investors section of our website at Www Dot <unk> dot com to find our third quarter 2023 business update press release and related financial tables.
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Yeah.
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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.
Okay.
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Joining me on today's call are Jim Dentzer President.
President and Chief Executive Officer, and Jonathan Zhang Our Chief Development Officer will also be available for a question and answer period at the end of our call.
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Now like to turn the call over to Jim. Thank you data.
Everyone and welcome to <unk> third quarter business update call.
Yeah.
This quarter marked a key inflection point for the company and for patients as we were able to return our focus to clinical enrollment and are taking leukemia, and taking lymphoma studies with the removal of the partial clinical hold.
Okay.
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Okay.
Later this morning abstracts for the 50 665 Ash annual meeting will be unveiled.
Ooh Ooh Ooh.
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And we are pleased to have several abstracts under consideration.
At Ash, we expect to provide an update from our take a lymphoma study, including our first look at proof of concept data for patients with primary CNS lymphoma, a rare form of extra nodal non hodgkin lymphoma for which there are limited treatment options.
And 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 flip three or spliceosome mutation.
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Enrollment of new patients has begun and we expect to have our first look at data from these patients in the first half of 2024.
Lastly.
We are working with clinical sites and regulatory authorities on advancing our new triplet study of <unk> in combination with Azacitidine and <unk> in AML.
Welcome to precision please hold for the next available operator.
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This study is intended to evaluate safety as well as <unk> ability to enhance the effectiveness of <unk> in vanilla clocks by studying AML patients, who are responding to <unk> and <unk> treatment.
But still have minimal residual disease or Marty.
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Our hope is that with the addition of <unk> to their treatment regimen.
We can help these patients convert from <unk> positive status to <unk> negative.
We expect to initiate this study in the fourth quarter and see initial data in the second half of next year.
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In short, we're making great progress in advancing the potential of <unk> as a monotherapy.
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As a doublet therapy, combining with ibrutinib.
And as a triplet therapy in combination with Azacitidine and venetic clocks, all of which should have data over the coming four quarters.
We look forward to providing those updates.
With that I'll turn the call back over to Dan to review, our financial results for the quarter Panther.
Next available operator.
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Panther thank.
Thank you Jim for the third quarter of 2023, <unk> reported a net loss of $12 2 million or $2 13 per share as compared to a net loss of $13 3 million or $2 83 per share for the same period in 2022.
<unk> reported a net loss of $35 7 million or $6 96 per share for the nine months ended September 32023, as compared to a net loss of $45 3 million or $9 82 per share for the same period in 2022.
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Revenues for the third quarters of 2023, and 2022 were both $2 8 million.
Thank you for calling session, which conference that Youre looking to join please.
Yes.
Revenues for both periods consists of royalty revenues from Genentech, Genentech and Roche's sales of <unk> revenues for the nine months ended September 32023, and 2022 were both seven $3 million.
Yes.
Thanks.
Thank you may start with your first and last name. Please.
Yeah.
Yes.
Mhm.
Okay.
Research and development expenses were $10 4 million for the third quarter of 2023 as compared to $10 8 million for the same period in 2020 to the.
Thank you and your company name please.
Okay.
Thank you I'll place you Eitan.
The decrease in research and development expenses for the quarter is primarily attributable to lower employee related cost due to reduction in head count partially offset by increased clinical com.
The conference is now being recorded 10 cents per share as compared to a net loss of $13 3 million or $2.83 per share for the same period in 2022.
Research and development expenses were $29 5 million for the nine months ended September 32023, as compared to $34 $6 million for the same period in 2022.
Curious reported a net loss of $35 7 million or $6.96 per share for the nine months ended September 30 of 2023 as compared to a net loss of $45 3 million or $9 82 per share for the same period in 2022.
General and administrative expenses were $4 8 million for the third quarter of 2023 as compared to $4 $6 million for the same period in 2022. The increase was primarily attributable to higher professional legal and consulting services cost.
Revenues for the third quarters of 2023, and 2022 were both $2 8 million Rev.
Revenues for both periods consists of royalty revenues from genetics, Genentech and Roche's sales of Arabic revenues for the nine months ended September 32023, and 2022 were both up $7.3 million.
General and administrative expenses were $13 $8 million for the nine months ended September 32023, as compared to $15 3 million for the same period in 2022.
Other income net was <unk> 2 million for the third quarter of 2023 as compared to other expense net of <unk> 7 million for the same period in 2022.
Research and development expenses were $10 $4 million for the third quarter of 2023 as compared to $10 $8 million for the same period in 2022, the decrease in research and development expenses for the quarter is primarily attributable to lower employee related cost due to a reduction in head count partially offset by increased clinical costs.
Other income and expense net primarily consists of interest income, partially offset by noncash expense related to the sale of future royalties.
Other income net was <unk> 4 million for the night.
Research and development expenses were $29 $5 million for the nine months ended September 30 of 2023 as compared to $34 $6 million for the same period in 2022.
For the nine months ended September 32023, compared to other expense net of $2 5 million for the same period in 2022.
As of September 30th 2023, curious as cash cash equivalents and investments totaled $68 5 million and there were approximately $5 9 million shares of common stock outstanding.
General and administrative expenses were $4 $8 million for the third quarter of 2023 as compared to $4 $6 million for the same period in 2022. The increase was primarily attributable to higher professional legal and consulting services costs.
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.
General and administrative expenses were $13 $8 million for the nine months ended September 32023, as compared to $15 $3 million for the same period in 2022.
With that I'd like to open the call for questions operator.
Thank you ladies and gentlemen, we will now begin the question and answer session should you wish to ask a question. Please press star followed by one on your Touchtone phone should you wish to withdraw your question. Please press star followed by two now.
Other income net was point 2 million for the third quarter of 2023.
As compared to other expense net of <unk> $7 million for the same period in 2022.
Other income and expense net primarily consists of interest income, partially offset by noncash expense related to the sale of future royalties.
And your first question comes from Yale Jen from Laidlaw <unk> Company. Please go ahead.
Other income net was <unk> 4 million for the night.
Good morning, and thanks for taking the questions and congrats on the progress.
For the nine months ended September 30 of 2023 compared to other expense net of $2 5 million for the same period in 2022.
Two questions here. The first question is in terms of the ash abstract.
As of September 30th 2023, curious as cash cash equivalents and investments totaled $68 5 million.
Two.
David.
Just to prevent to present.
And there were approximately $5 9 million shares of common stock outstanding.
Could you give us little bit color you'd mentioned theres more than one so.
We continue to be in a strong cash position.
Position and expect that our existing cash cash equivalents and investments should enable us to maintain our planned operations into 2025.
General contact love that didn't have a problem.
So thank you <unk> I appreciate that.
So we're going to defer most of the comments about the ash abstracts until the abstracts go lives. However, what I would say is that we've got leukemia and lymphoma ongoing.
With that I'd like to open the call for questions operator.
Thank you ladies and gentlemen, we'll now begin the question and answer session should you wish to ask a question. Please press star followed by one on your Touchtone phone should you wish to withdraw your question. Please press star followed by two.
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 in Ash story.
I'll now.
Your first question comes from Yale Jen from Laidlaw and company. Please go ahead.
Pharma is really going to be the new data that are coming at ash and as we've talked about before we have in the past looked at monotherapy and combination therapy.
Good morning, and thanks for taking the question.
Congrats on the progress.
We've established our dose.
Two questions here. The first question is in terms of the ash abstract.
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 first.
Two.
David.
The present to present.
Could you give us little bit color, you had mentioned theres more than one so what's.
An orphan indication within lymphoma.
So that means a relatively small number of patients would be needed.
What's the general context of that didn't have a follow up.
On the regulatory path.
Yeah. So thank you I appreciate that.
Second.
There is a very clear unmet need.
So we're going to defer most of the comments about the ash abstracts until the abstracts go live however, what I would say is that we've got leukemia and lymphoma ongoing.
There is an established benchmark for what Ibrutinib looks like in monotherapy in.
In primary CNS lymphoma, ibrutinib attained a 19% CR rate.
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 a Nash story Glynn.
And then.
It really is going to establish what I hope to be in.
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 to Ibrutinib, but also can we get crs in patients.
Lymphoma is really going to be the new data that are coming at ash and as we've talked about before we have in the past looked at monotherapy and combination therapy. We've.
Who have progressed.
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 first it is an orphan indication within lymphoma.
PTK treatment.
Can they be re sensitize that has always been the hypothesis for <unk>, who started in Iraq for inhibition. This will be the first time, we can see data to see whether or not that that's possible.
So that would be my expectation for reviewing the data at ash.
So that means a relatively small number of patients would be needed on the regulatory path.
Leukemia, a 2024 story the <unk> is going to be lymphoma.
Second.
There is a very clear unmet need.
Okay, Great that's helpful and.
There is an established benchmark for what Ibrutinib looks like in monotherapy in.
The second question here.
You have mentioned earlier that before that.
In primary CNS lymphoma, ibrutinib attained a 19% CR rate.
Hi, Rick.
Mds.
Development well it depends on what you see.
And then.
But the sort of standard of care potentially it could be established so you would set up.
It really is going to establish what I hope to be in.
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 to Ibrutinib, but also can we get crs in patients.
What are you doing that.
And what's your current thoughts in terms of that.
No that's exactly right.
By standard of care.
As you know the standard of care in AML is the <unk> doublet.
Who have progressed.
On PTK treatment.
Can they be re sensitize that has always been the hypothesis for MF, who started in Iraq for inhibition. This will be the first time, we can see data to see whether or not that's that's possible.
Today as we stand the standard of care in Mds is decided in monotherapy.
Inside of the <unk> study is still pending.
So that would be my expectation for reviewing the data at ash.
That's the <unk> study and those results presumably are imminent.
Leukemia is a 2024 story the Astoria is going to be lymphoma.
So we are waiting to see of course is if that study is positive or negative if that study is positive and the doublet is also the standard of care in Mds will want to proceed with the triplet if on the other hand, it's negative and <unk> remains as monotherapy at the standard of care. Then we would look to proceed with a doublet.
Okay, Great that's helpful and.
The second question here is that you.
You have mentioned earlier that before that.
High risk.
Mds.
Development will it depends on what you see.
Is that helpful.
But the sort of standard of care potentially could be established so you would set up.
Oh absolutely.
Great.
Okay.
What are you doing that.
Well maybe.
And what's your current thoughts in terms of that aspect.
Any timeline, you can sort of back to the display.
We don't run that study. So unfortunately, no I mean, I think what the broader world is expecting is there.
No that's exactly right so by standard of care.
As you know the standard of care in AML is the <unk> doublet.
It's somehow.
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.
Today as we stand the standard of care in Mds is decided in monotherapy.
<unk> study is still pending.
Okay, Great Thats very helpful.
That's the Verona study.
Again, congrats on the progress and look forward to.
Those results presumably are imminent.
Do you think that that thank.
So we are waiting to see of course is if that study is positive or negative if that study is positive and the doublet is also the standard of care in Mds will want to proceed with the triplet if on the other hand, it's negative <unk> remains as monotherapy at the standard of care. Then we would look to proceed with a doublet.
Thank you very much.
Your next question comes from Lee <unk> from Cantor Fitzgerald. Please go ahead.
Hey, good morning, Thanks for taking our questions Jim maybe.
Can you just frame Ali expectation for us a little bit for the data update.
Is that helpful.
First half of next year.
Oh absolutely.
Color E M L.
But are there.
And maybe what.
Mds, what the bar will be.
Any timeline, you can sort of back to lay a display.
Yes, so in AML and Mds.
We don't run that study. So unfortunately, no I mean, I think what the broader world is is expecting is there.
It's going to be separate right. So we are proceeding with monotherapy in patients in relapsed in the relapsed refractory setting for flip three.
It's somehow.
Sometime over the next few months, whether that's ash or sometime in early 2024.
And spices home patients and Mds has passed.
Of course, we don't know any more than you do but we are eagerly awaiting the outcome of those data.
Asked about where we're really awaiting news of the Verona study to make sure we understand the path forward.
Okay, Great that's very helpful.
<unk> three.
Again, congrats on the progress and look forward to.
And spliceosome.
The benchmarks are pretty clear.
Do you think that bench.
Flip three CR rate with Gill to written them at <unk> as you know is the market leader for flip three inhibitors.
Thank you very much.
Your next question comes from Lee <unk> from Cantor Fitzgerald Li. Please go ahead.
Is 12%.
So of course, we would look to want to improve on that.
Hey, good morning, Thanks for taking our questions Jim maybe.
CRH rate was 22, 6% and of course, we would want to improve on that in spliceosome patients.
Can you just frame the expectations for us a little bit for the data update in first half of next year.
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 the only data in the literature.
Color E M L.
And Mds, what the bar would be.
Yeah. So.
AML and Mds.
It's going to be separate right. So we are proceeding with monotherapy in patients in relapsed in the relapsed refractory setting for flip three.
Addressing spliceosome patients is that they have the worst of the worst prognosis. So as you know in relapsed refractory AML.
The survival is unfortunately quite poor.
And spices home patients and Mds has passed.
Median survival in studies ranges from two to four months.
I asked about where we're really awaiting news of the Verona study to make sure we understand the path forward in flit three.
And what we understand from the literature is that the lower end of that range is for the spice in some patients, but as far as we know nobody's ever demonstrated you can get a response so insulet three.
And spliceosome.
The benchmarks are pretty clear.
Flip three CR rate with Gill to written I mean, <unk> as you know is the market leader for flip three inhibitors is 12%.
What we're looking to do is can we improve upon flit three inhibitors as a class.
With our fleet three Iraq for.
Targeting molecule.
So of course, we would look to to want to improve on that.
And that would be beating a 12% CR rate or a 22, 6% CR CRA trade.
CRH rate was 22, 6% and of course, we would want to improve on that in spliceosome patients.
And in spices home patients it would be.
Anything that would be greater than zero of it presumably something north of 10 would be very exciting in that setting.
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 the only data in the literature.
Is that helpful. Okay, yes.
And I have another question for the triplet.
Addressing splices home patients is that they have the worst of the worst prognosis.
Do you think you need to do more work for the company Shen and also do you anticipate any drug drug interaction with it.
As you know in relapsed refractory AML.
The survival is unfortunately quite poor.
<unk> survival in studies ranges from two to four months.
Management.
Excellent question. So the answer to the second one of do we expect any DDI drug drug interaction I would say, we don't expect it based on the work we've done in the lab and clinical work. We've done to date, we don't see that there's an overlapping safety profile that said of course, that's why you run the studies to see whether or not that stays.
And what we understand from the literature is that the lower end of that range is for the spice in some patients, but as far as we know nobody's ever demonstrated you can get a response so in flip three.
What we're looking to do is can we improve upon flit three inhibitors as a class.
With our flight III Iraq for.
System.
Sure.
Targeting molecule.
In terms of our expectation.
And that that would be beating a 12% CR rate or at 22, 6% CR Cri trade.
Could you remind me where you were headed with that first part of the question in.
In the triplet.
Do you need to do more work.
And in spices home patients it would be.
Anything that would be greater than zero of it presumably something north of 10 would be very exciting in that setting.
That's right so.
So the answer to that is yes, I mean, our first our first.
Is that helpful. Okay, yes.
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, we think we have the right dose.
And I have another question for the triplet.
Do you think you need to do more work for the company Shen and also do you anticipate any drug drug interaction with it.
In combination with Ibrutinib and genetic box, but this will be the first time. We've studied the triplet in the clinic of of Asia and then in analog.
<unk>.
Excellent question. So the answer to the second one or do we expect any DDI drug drug interaction I would 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's an overlapping safety profile that said of course, that's why you run the studies to see whether or not that.
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 dose and regimen for <unk> in that setting.
Stays consistent.
Okay.
In.
Of our expectation.
Okay.
Any other questions Lee.
Could you remind me where you were headed with that first part of the question.
No that's great. Thank you.
In the triplet.
Excellent. Thank you.
Do you need to do more does work.
Your next question comes from Dane Leone from Raymond James. Please go ahead.
Oh, that's right so.
So the answer to that is yes, I mean, our first 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, we think we have the right dose.
Okay.
Okay.
Okay.
Got it.
He disconnected from the line.
Your next question comes from a J Rashid from Colombia equal Hey, Jay. Please go ahead.
Combination with Ibrutinib and phonetic box, but this will be the first time. We've studied the triplet in the clinic of of Asia, and then an analyst. 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 <unk> in that setting.
On the Oberlin dispute.
Okay.
Yeah.
That last one broke up.
I'm sorry about that are there any other questions in the queue.
Yeah.
Okay. It appears there are no further questions.
Okay.
So.
This concludes our question and answer session I would like to turn the conference back over to the company's President and Chief Executive Officer, James Dentzer.
Any other questions Lee.
No that's great. Thank you.
Excellent. Thank you.
For any closing remarks thank.
Your next question comes from Dane Leone from Raymond James. Please go ahead.
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 curious for their tireless commitment.
Okay.
Okay.
Yeah.
Okay.
Yes.
And to our partners at origin and the NCI for their ongoing help and support we look forward to updating you again soon.
He disconnected from the line.
Your next question comes from a J.
<unk> from Columbia Eagle, Hey, Jay. Please go ahead.
Thank you.
Ladies and gentlemen, this concludes your conference call for today, we thank you for participating and ask that you. Please disconnect your lines.
On the Oberlin dispute.
Okay.
Yeah.
Okay.
That last one broke up sorry about that are there any other questions in the queue.
Okay. It appears there are no further questions.
So.
This concludes our question and answer session I would like to turn the conference back over to the company's President and Chief Executive Officer, James Dentzer for any closing remarks.
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 curious for their tireless commitment.
And to our partners at origin and the NCI for their ongoing help and support we look forward to updating you again soon.
Thank you.
Ladies and gentlemen, this concludes your conference call for today, we thank you for participating and ask that you. Please disconnect your lines.
Okay.
Okay.