Q4 2022 Curis Inc Earnings Call
Good morning, and welcome to the curious fourth quarter 2022 business update call.
All participants will be in listen only mode.
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After the Companys prepared remarks, all participants will have an opportunity to ask questions.
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I would now like to turn the conference over to Diantha Duvall jurist as Chief Financial Officer Diantha. Please go ahead.
Thank you.
And welcome to the curious fourth quarter 2022 business update call before we begin I would like to encourage everyone to go to the investors section of our website at Www Dot curious dot com to find our fourth quarter 2022 business update 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 and actual results may differ materially for additional details. Please see our SEC filings.
Joining me on today's call are Jim Dentzer, President and Chief Executive Officer, and Bob Martell head of R&D. We will also be available for a question and answer period at the end of the call I'd like now to turn the call over to Jeff.
Thank you Diana good morning, everyone and welcome to curious as fourth quarter business update call.
This past quarter, we made important progress with our lead clinical candidates and Magoo circuit, which is currently being evaluated in two clinical studies to take game leukemia study.
As one two studies with both monotherapy and combination arms for patients with relapsed or refractory acute myeloid leukemia, or AML and high risk myelodysplastic syndromes or Mds.
And the taking lymphoma study.
Our phase <unk> combination study with Ibrutinib.
For patients with relapsed or refractory NHL and other hematologic malignancies.
We were especially pleased to present, an update of clinical data from the take game leukemia study in which AML patients with a flip three mutation had a CR rate of 29%.
AML patients with a spliceosome mutation had a CR CRH rate of 22% and M. D. S patients with a spliceosome mutation had an overall response rate of 45% with all five responses achieving a marrow complete remission.
This update doubled the size of our earlier dataset and reaffirmed <unk> potential to be an important therapeutic alternative for patients with AML or Mds.
We've also made important progress in our work to resolve the partial clinical hold on our leukemia study in last quarter's call, we announced that the FDA had approved the reopening of our clinical sites. So that we could enroll nine additional patients at the 200 milligram dose level to facilitate discussions with F. D. A.
On the recommended phase two dose or RP, two D and the resolution of the partial clinical hold.
We're pleased to announce today that we have completed the reopening of our sites and have also completed the enrollment of the nine additional patients requested by FDA. This is ahead of schedule and we believe reflects the excitement surrounding this novel therapeutic and the critical unmet need in this sorely underserved patient population.
Yeah.
We expect to collect data for these patients in Q2 and meet with FDA in Q3 to review those data.
We also continue to enroll in our taking lymphoma study in which we are focusing on primary CNS lymphoma, and treating patients with the combination of M. A asserted and ibrutinib.
In short we had a very productive end of 2022 and that momentum has carried forward into 2023 we look forward to working with the FDA in the months ahead to gain alignment on our P. T D. In our T game leukemia study and resolution of the partial clinical hold.
With that I'll turn the call back over to Diantha to review our financial results for the quarter Panther. Thank you Jim for the fourth quarter of 2022 cures reported a net loss of $11 3 million or <unk> 12 per share as compared to a net loss of $13 6 million or <unk> 15 per share for the same period in 2021.
Im.
<unk> reported a net loss of $56 7 million or 61 per share for the 12 months ended December 31, 2022, as compared to a net loss of $45 4 million or <unk> 50 per share for the same period in 2021.
Revenues for the fourth quarters of 2022, and 'twenty, 'twenty, one or 2.9 million and $3 1 million respectively revenues for the 12 months ended December 31, 2022, and December 31, 2021 were $10 2 million and $10 6 million respectively.
Operating expenses for the fourth quarter of 2022 were $13 1 million as compared to $15 7 million for the same period in 2021.
Operating expenses for the 12 months ended December 31, 2022 were $63 2 million as compared to $52 7 million for the same period in 2021.
And consisted the following royalty revenues, which comprised amounts due to third party University patent license license source in connection with the Genentech and Roche Arab beds net sales were <unk> 1 million for the fourth quarter of 2022 as compared to point 2 million for the same period in 2021.
Cost of royalty revenues for the 12 months ended December 31, 2022, or <unk> 3 million as compared to <unk> 5 million for the same period in 2021.
Research and development expenses were $8 7 million for the fourth quarter of 2022 as compared to $10 8 million for the same period in 2021 the.
The decrease in research and development expense for the quarter is primarily attributable to decreased personnel manufacturing and clinical development costs research and development expenses were $43 3 million for the 12 months ended December 31, 2022, as compared to $34 9 million for the same period in 'twenty one.
General and administrative expenses were $4 3 million for the fourth quarter ended December 31, 2022, as compared to $4 8 million for the same period in 2021.
A decrease in general and administrative expenses was driven primarily by a decrease in personnel costs.
General and administrative expenses were $19 6 million for the 12 months ended December 31 2022.
As compared to $17 3 million for the same period in 'twenty one.
For the fourth quarters of 'twenty, two and 21 total other expense was $1 1 million respectively.
Other expense was $3 7 million for the 12 months ended <unk> <unk>.
December 31, 2022, as compared to $3 4 million for the same period at 2020 one.
Other expense net for the year ended December 31, 2022, primarily consisted consisted of expense related to.
Future royalty payments, partially offset by interest income.
Other expense net for the year.
Ended December 31, 2021, primarily consisted of imputed interest expense related to future royalty payments, partially offset by a gain recognized upon the forgiveness of the PPP loan.
As of December 31, 2022 curious as cash cash equivalents and investments totaled $85 6 million and there were approximately $96 6 million shares of common stock outstanding.
We continue to have a strong cash position and expect our existing cash cash equivalents and investment investments shouldn't it should enable us to maintain our planned operations into 2025 with that I'd like to I'd like to open up the call for questions operator.
We will now begin the question and answer session.
Ask a question you May press Star then one on your telephone keypad.
If youre using a speakerphone please pick up your handset before pressing the keys.
To withdraw your question. Please press Star then two.
Once again it was star then one to ask a question at this time, we will pause momentarily to assemble the roster.
And our first question will come from Ed White of H C. Wainwright.
Got it.
Good morning, Thanks for taking my questions.
Jim previously you had said that taking in lymphoma, you had expected data in 2023 now that were in 2023 can you give us a little bit of guidance as to when.
We should expect to see that data in this year.
Hi, Thanks, Ed Thanks for calling in.
I think where our expectation remains the same that we're hoping to provide an update by year end if things change between now and then of course, we'll let you know, but we're very pleased with where we stand in both studies.
Great Thanks and.
You didn't mention the Vista program at all I know, it's been halted I just wanted to get your thoughts on.
Is anything changing there is there are any thoughts being given to restarting. This program in 2023 or is that perhaps.
More are.
Out there further.
Well, Yeah, I think I think it's premature for us to think about restarting. It just yet you remember the reason we paused it had nothing to do with our excitement about the program. That's a terrific target. It's terrific program, we were making really nice progress I thought I think it was more about given the financial climate, we needed to cut back our cash burn in order to ensure that.
One to 2025 and until we get to a point, where we're confident that the market is different or that that we've got the ability to access cash that doesn't put.
You know any compromising them.
Impact onto Iraq War, we need to go all in on Iraq War So.
As I said, we're really excited for where we are right now I think we're in a great position to add value to the Iraq War program. This year, and we will be keeping our eye on the financial markets more broadly as we go through the course of 2023.
Okay. Thanks, Jim since you brought up financials, maybe a question for Dan just regarding the your thoughts on R&D expense.
Throughout the year.
As the development of that but it gets back on track.
How should we be thinking about the ramp where perhaps.
Just not a ramp or a flattening of the R&D expense.
So so and if you if you recall, we announced our our re prioritization in November and I think Q4 is your U as we said that the costs are coming down so I think sort of where we sit in Q4.
We'll likely sort of be the sort of ongoing run.
Run rate, although I will say it could come down a little bit further just by virtue of the fact, we did not avail ourselves of the full quarter, Our post street, we prioritization.
Yeah.
Okay, great. Thanks for taking my questions.
Our next question comes from Sumit Roy Jones trading. Please go ahead.
Good morning, everyone and congrats on all the progress of the nine patients you mentioned the additional new patients enrolled are these I'll email patients. So they're a N M. D. S. If you can give us.
Some idea and.
Also do you think if you can provide any color on if they are very late line patients says he has seen.
Prior to the whole tool enrollment holds do you were getting more late line patients.
Hey, Matt This is Bob Martell, Yeah were.
Currently you know really trying to address the fda's question around the the dosing and in particular at the lower dose of 200 milligrams and so we've enrolled these nine patients as part of the regular phase one protocol, which is open to both AML and Mds.
You know, we we noticed that our pace.
Patients many of the patients that we've enrolled on the study has had lots of prior lines of therapy.
And that's obviously a challenging population to treat so you know.
While we're not restricting per se, we always seek patients who perhaps a little bit earlier in their lines of therapy, but you know for these nine patients we havent made specific guidelines.
Totally understandable, that's really helpful and one last question is.
You previously had for patients on it came up we said tube and venetic lax combination with 50% response rate and can you confirm if these patients are still being treated.
Yeah.
Yeah, we haven't really given any updates on the since the ash presentation.
We're not prepared on this call to provide any further detail other than the fact that.
The data that we saw was quite impressive where we had deep responses in you know in the patients a M. L. M D S.
Three out of the four patients who had responses of Vale.
Assessments available had pretty dramatic reductions in their blast counts and as you mentioned two of them with.
Getting their blast coming back to normal so as you know.
Just to talk a little bit to the mechanism.
Vanilla class hits Bcl, two well the other major anti apoptotic factor.
In these patients that's preventing the cancer from undergoing apoptotic says is mcl, one and in fact are.
Hitting Iraq for reduces Mcl one so we think this is a great potential combination from a mechanistic standpoint, and we're really excited ultimately to get more data on.
That combination.
Thank you for taking the questions and congrats on all the progress.
Thanks Sherman.
Okay.
The next question comes from Yale Jen of Laidlaw and call.
Go ahead.
Good morning, and thanks for taking the question.
Just call. It a night patient you recently completed Oh, they have any sort of difference compared to the prior patients or are they out very much the similar to the one you have you enrolled it before.
Yeah, Hey, Yale Jen I would say you know they theres basically similar for all intents and purposes to prior patient center phase one.
You know in general where we're enrolling patients essentially last line patients who've had all available therapies and so again. These patients there are in a very difficult situation and.
Like we've said before.
The fact that we've been seeing efficacy such striking efficacy in the earlier patients is pretty amazing.
So we're just continuing to enroll that same population eventually once we identify a recommended phase two dose will be as we've mentioned selecting targeted patients who are you.
Much more likely to respond so patients with the two splicing factor mutations SSB B, one and Youtube F. One will be selecting only those patients going forward once we get to a recommended dose. Similarly, the flit three mutation as well that's another selected patient population that will be invested.
<unk> in the future as soon as we get a recommended dose.
Okay, Great and maybe just elaborate a little bit more in terms of the previous question, which is the what do you anticipate what do we see any read through from the Ash meeting. So the data is presented not too long ago and thanks.
Well I think the biggest read through from my perspective was the fact that as you remember back in 2022, we had had pretty striking data.
Early early in the year.
Towards the soda ash of of the year prior one of the exciting things about ash. This last year was that we essentially doubled the patient population and continued to see continue.
Continue to see very dramatic activity, including multiple new responses.
Oftentimes you can get a you know a signal in the first couple of patients and then it never pans out in the end well in this case, it's continuing as we expand our database and also you know.
The fact that these patients are having really durable responses when they get a response you know over six months and.
Almost all of the patients had had prior HMA.
Which is as you know a very difficult patient population to treat.
Yeah.
The median survival as we've said before in AML for these patients is about two and a half months. So we've been really excited to see the data that we've gotten so far and <unk> and that was really the big read through is that we continue to get at is where do you like essentially doubling the patient population.
Okay, Great that's very helpful.
Best of luck for more work.
Thank you.
Once again, if you would like to ask a question. Please press star one.
And our next question will come from Lee <unk> of Cantor Fitzgerald. Please go ahead.
Hi, Matt It's anybody's my answer Lee. Thank you so much for taking our question.
So regarding the nine patients in your discussion with the SBA would you be able to tell us potentially what types of data you would be collecting and talking about with them.
And when do you anticipate you might communicate the feedback with the street after the <unk> meeting.
Well, let me start with the data and then maybe Jim can talk about the communication.
So the F D a is.
You may be familiar with project Optimists. So let me start from there. This is a effort that the F. D. A has undertaken in the last year or so to try to participate much more in the determination of the recommended phase two dose for essentially all oncology drugs that are going to phase one and so they've they've kind of set.
Some some guidelines around this and one of which is <unk>.
Exploring multiple doses, where there is some efficacy and safety. So you know in the.
Example of M. A assertive we've had actually three doses that met our safety criteria, meaning that they we felt that they were safe. They didn't have a you know a high rate of dose limiting toxicities, but all three doses also had some efficacy.
We had explored the 304 hundred dose twice daily.
And felt that the you know the.
The 300 offer comparable efficacy to the 400, when we evaluated that well we had originally only evaluated three patients at the 200. So the FDA just wanted us to explore that a little bit more and that's the goal for the nine patients is to get that total up to 12 patients. So that since we did.
Some efficacy at that dose level, they wanted to better understand that as well and ultimately that's the driving force around why they've asked us for this.
And when we don't think this is unique to curious or M. A looser too, but I think that they are really doing this for you know all companies who are in their early phase one development.
Thanks.
Yeah, let me add to that leap so far.
First one.
When we talk about the different dose levels.
Bob said, we know project optimists as about trying to find the lowest dose that can lead to that optimal efficacy level I think one of the things that gets us. So excited is that all of the doses at 203 hundred and 400 that we tested have efficacy that's the good news.
It's also the good news if you're interested in project Optimus because of course.
It means you want to make sure you're fully explore those.
The question about data that we would have by the end of the year. You know, we're still anticipating that we're going to have a data in both leukemia and lymphoma by the end of the year. My hope is that we're going to have some output from FDA as well to talk about whether or not we ended up at 200 or 300 remains to be seen of course.
Right now, we're just doing everything that the FDA has asked and we are thrilled that we were able to get the sites open and patients enrolled ahead of schedule and I think as I as I said in my comments. It reflects the both the the dire situation that these patients are in the critical unmet need and the excitement among our investigators to get this new.
Therapy in treating patients and Leah and just to give a little bit more detail on the specific data one thing that the FDA really likes is what they call an efficacy response analysis and so I'm sorry.
Exposure response analysis, so what they look at closely as the actual.
Exposure of MMF, who search him in each patient. So as you know we're doing detailed pharmacokinetic analyses on all of these patients. So they'll look at that they will compare that to safety they'll compare it to efficacy and that will help give them and us are very granular understanding of the optimal dose and so that's.
Really the fundamental aspect of what we're going to be looking for.
I'm sorry, maybe just one quick follow up if you could potentially have you and hold less good and great cure for you how quickly do you think you could restart.
Well, we're already the studies are actually already opening and going so it would essentially be you know once we have that agreement. The studies are already open and we continue with that dose level. So I don't anticipate any significant delay once that happens yeah. Rosemary let me add to that so that was when I said it kind of quickly in.
The comments, but of course, when we went on hold.
You have to effectively shut your site's down.
Right the big change that we had at the end of last year was they allowed us to resume enrollment. So we went through the process already in Q4 are getting all of our sites open and then and then recruiting new patients so to bobs point as far as the FDA is concerned we are open.
You know, where we needed to recruit those nine patients, but that's now done we're now in the process of wait for the data and give it to the F. D. A N C, which dose they prefer do they prefer 200 or 300, either way our sites are open and we're off to the races.
As soon as you get the dose you can Scott.
We can continue and enrollment at that dose, which ultimately.
We feel like we can accumulate data there were interested in you know, let's step back and think about our overall potential Registrational plan. So we've mentioned there's a couple of opportunities for very rapid registration and that would be single arm studies in flit three mutated in patients with <unk>.
<unk> three mutated AML and secondly in patients with splicing factor mutated AML and so those are single arm studies soon as we have our dose we can start expanding that and really at that point, having much greater clarity on what.
Our Registrational plan will be.
Got it. Thank you so much for answering my questions.
Thank you Rosemarie.
This concludes our question and answer session I would like to turn the conference.
The company's president and Chief Executive Officer.
For any closing remarks thank.
Thank you operator, and thank you everyone for joining today's call and as always a thank you to the patients and the families participating in our clinical trials to our team at <unk> for their hard work and commitment and to our partners at origin Immunex and the NCI for their ongoing help and support we look forward to.
Dating you against them.
Operator.
The conference has now concluded.
Thank you for your participation.
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