Q3 2022 Curis Inc Earnings Call
Good afternoon, and welcome to curious as third quarter 2022 business update call. All participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.
After the company's prepared remarks call participants will have an opportunity to ask questions to ask a question. You May Press Star then one on your Touchtone phone to withdraw your question. Please press Star then two.
Please note this event is being recorded.
I'd now like to turn the conference open secures as Vice President of Investor Relations and corporate Communications Craig West. Please go ahead.
Thank you and welcome to curious as third 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 third quarter 2022 earnings 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 join.
Joining me on today's call are Jim Dentzer, President and Chief Executive Officer Diane.
Diantha Duvall, Chief Financial 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 now like to turn the call over to Jim.
Thanks, Greg Good afternoon, everyone and welcome to curious as third quarter business update call.
Every day, we strive to develop the next generation of first in class cancer therapies.
Meaningfully improve and extend patients' lives.
Earlier today, we announced that based on new data. We have received and are taking leukemia study. We've made the decision to focus the company's resources unexploited, the task of bringing <unk> to patients.
This focus on M, a who started.
And the corresponding deep prioritization of our other programs will enable a reduction of approximately 30% of the company's workforce and is expected to extend the company's cash runway into 2025.
At this time I'd like to acknowledge that while we are excited about the heightened focus if I move to start it we understand the impact of de prioritizing. Our other programs has on our valued colleagues and friends who worked on them. We're grateful for all of their hard work and we wish them well as they pursue new opportunities.
Let me turn now to discuss Emma's uncertain and the development activities going on to drive this important asset forward starting with our recent accomplishments.
During the quarter.
We were pleased to announce that the FDA has approved the reopening of enrollment in our T games studies in leukemia and lymphoma.
Also in the quarter, we sponsored the first annual symposium on Iraq for this.
This event brought together academic and industry experts to discuss the latest groundbreaking research in Iraq for.
The event was well attended informative and frankly it was a lot of fun to hear about all the great work going on in this important answer.
Area of cancer biology.
We were honored to make the event possible.
And a host so many of the brilliant pioneers advancing the science of Iraq for.
This coming quarter will.
We will be releasing new data in our take aim leukemia study of Emmalou sorted at the 64th annual meeting of the American Society of Hematology in New Orleans.
These data will include 11 additional patients treated with monotherapy in our targeted populations those patients whose disease harbors flit three or spliceosome mutations.
These 11, new patients, bringing the total number of patients with targeted mutations to 'twenty four.
As many of you know there are currently no drugs approved for relapsed refractory AML or Mds patients post treatment with HMA.
The only published data available for the post HMA setting.
Our for M D S patients treated with chemotherapy.
8%.
Or are was observed.
We're very excited to be developing what we hope will be a game changing therapy for patients who face such a significant unmet need.
As a reminder, in mobile search or is currently being evaluated in three separate clinical studies.
First.
The taking leukemia studies phase one two study with both monotherapy and combination arms for patients with relapsed or refractory acute myeloid leukemia, or AML and high risk Myelodysplastic syndromes or M. D S.
They take game lymphoma study.
<unk> one two combination study with ibrutinib for patients with relapsed or refractory NHL and other hematologic malignancies.
And third.
The phase two Lucas study evaluating <unk> in patients with lower risk Mds.
The take aim leukemia study is open for enrollment in monotherapy at the 200 milligram dose level, we plan to enroll at least nine more patients at this dose and discuss data from those patients with F. D. A.
Provided we received the agency's agreement in those discussions we plan to reopen enrollment in the studies expansion arm as well as in a combination arm investigating and mobile search it with Asus iodine or venetic blocks.
Staying with leukemia and M D S for a moment.
We believe that the Lucas study in lower risk Mds could have a data readout in the first half of 'twenty twenty-three.
Recall that the Lucas study is an investigator sponsored study led by Dr. ULE plots Becker chairman of <unk> scientific working group on M. D S.
We're excited to see what M. A assertive shows in this study as spliceosome mutations are among the most prominent mutations in lower risk Mds.
Yeah.
In an exciting new and more recent development. We note that curious will be presenting at city right here in Boston later this week.
This presentation will highlight an investigation of the immune modulation that occurs with IraQ4 inhibition in melanoma brain metastases.
This is yet another example of the vibrant level of scientific research going on around Iraq War and demonstrates that <unk> potential quite possibly extends to solid tumors as well as leukemia and lymphoma.
In summary progress this quarter as highlighted by receiving FDA approval to reopen enrollment in both of the take games studies.
Convening the first Iraq for symposium.
Announcing the release of new clinical data at Ash.
And announcing the extension of the Companys cash runway and additional year into 2020 five.
It has been an eventful quarter and we look forward to providing important updates on M. <unk>, who started at tsetse ash and at other events in the weeks and months ahead.
With that I'll turn the call over to Diantha to review our financial results for the quarter Panther.
Thank you Jim.
<unk> today has a strong foundation, both operationally and financially to allow us to concentrate on M a voice or tip.
Development for the third quarter of 2022 carriers reported a net loss of $13 3 million or 14 cents per share.
As compared to a net loss of $11 1 million or 12 cents per share for the same period in 2020 one.
Curious reported a net loss of $45 3 million or 49 cents per share. The nine months ended September 30th 2022 as compared to a net loss of $31 8 million or 35 cents per share for the same period in 2021.
Revenues for the third quarters of 'twenty, 'twenty, two and 'twenty, 'twenty, one or 2.8 million and 3 million respectively.
Revenues for the nine months ended September 30th 2022 and September 30th 2021 were $7 3 million and $7 5 million respectively.
Operating expenses for the third quarter of 2022 were $15 4 million as compared to $13 1 million for the same period in 2020 one.
Operating expenses for the nine months ended September 30 of 2022 were $50 1 million as compared to 37 million for the same period in 2020, one and consist of the following.
Cost of royalty revenues, which comprised which is comprised of amounts due to third party University patent license stores in connection with Genentech and Roche's average net sales were point 1 million for the third quarter of 2022 as compared to point 2 million for the same period in 2021.
Cost of royalty revenues for the nine months ended September 32000, 22.2 million as compared to point 4 million for the same period in 2021.
Research and development expenses were $10 8 million for the third quarter of 2022 as compared to $8 6 million for the same period in 2021 the.
The increase in research and development expenses for the quarter is primarily attributable to increased personnel and consulting costs, partially upset by a deep by decreased manufacturing and clinical development costs.
Research and development expenses were $34 6 million for the nine months ended September 32022.
As compared to $24 1 million for the same period in 2021.
General and administrative expenses were $4 6 million for the third quarter ended September 30th 2022 as compared to $4 3 million for the same period in 2021 the.
The increase in general and administrative expenses was partially.
Was driven primarily by the timing of costs General and administrative expenses were $15 3 million for the nine months ended September 30 of 2022 as compared to $12 5 million for the same period in 2021.
For the third quarter of 2022, and 2021.
Total other expense was <unk> 7 million and 1 million respectively.
Other expense primarily consisted of imputed interest related to the future royalty payments, partially offset by interest income.
Other expense was 2.5 million for the nine months ended September 32022, as compared to $2 3 million for the same period in 2021.
As of September 30th Twenty-twenty, too curious as cash cash equivalents and investments totaled $98 7 million and there were approximately $96 4 million shares of common stock outstanding.
We are in strong cash position and expect that our existing cash cash equivalents and investments should enable us to maintain our planned operations into 2025.
With that I'd like to open the call for questions operator.
We will now begin the question and answer session.
To ask a question you May press Star then one on your telephone keypad.
If you were using a speakerphone please pick up your handset before pressing the keys to withdraw your question. Please press Star then two.
At this time, we will pause momentarily to assemble our roster.
Our first question is from Ed White with H C. Wainwright. Please go ahead.
Good afternoon, Thanks for taking my questions.
A couple of questions on.
The.
Head count reduction.
So.
It is the impact going to be felt more in the G&A or the R&D expense line.
And shall we be seeing the impact.
Starting in the fourth quarter or is this going to be really a.
'twenty 'twenty three event.
Where the impact on expenses.
Thanks, Ed first thanks for taking the question.
So the impact is really it's across the company. It is it is both G&A and R&D, obviously it starts with.
Everything that's not directly related to EMS search. It. So we are we are absolutely concentrating all of our resources towards MMO circuit, and therefore anything that wasn't directly related with something that we could live without and if we could live without and that extended our cash runway without having to do anything else. I mean this is the luxury.
<unk> of starting with such a strong balance sheet that we have this flexibility, but with these data in it becomes increasingly clear that that this is a drop and this needs to get to NDA submission with haste. So we're going to dedicate and redouble all of our efforts to make that happen and insulate ourselves from the need to raise money in the meantime.
So yeah broad based across G&A and R&D, there will be some impact in Q4, but it's really as you look out over the full two year period that follows that youll see that that cash runway impact.
Okay. Thanks, Jim and then I'm, just curious with the Vista program.
Will we be seeing more data from 899 three.
What's going to happen to patients that are currently enrolled if they're already.
And is are you looking at this as just halting the program for now.
Or is this something that you might want to partner or out license for someone else to bring forward.
I think that this is as more of a of a pause a suspension of activity, we're not enrolling new patients in that study as you know we loved the Vista target I think it's fantastic.
But in a world, where you've got two programs in the clinic.
And one of them has has really not just proven data that it shows it works consistent consistently from theory to lab to clinic, but you now have a new batch of clinical data that shows you've got an idea N D E.
And then the other program is still in dose escalation. If you can't afford to do both boy the decisions clear you go with the one that's got the proven data so I love this as a target.
But we need to we need to take the effort in the money and the people that are dedicated to that program right now and be laser focused on R&M up from startup.
Okay that makes sense. Thanks for taking my questions sure. Thank you.
The next question is from Sumit Roy with Jones Research. Please go ahead.
Hi, everyone. Congrats on all the progress.
Quick one on the expected ash data from the monotherapy on the combo arm could you give us any color on what kind of duration of drug these patients will be.
We as a just 20 diesel is longer than that since he just started enrolling.
So it took a little longer than that and it includes data for some patients as you may remember we were put on clinical hold last spring. So we had some patients that had just started the study before the FDA halted enrollment of new patients. So we've got.
The data is related to those patients incrementally.
I do think obviously, it's a significant add to the dataset, it's almost doubling the number of patients. We've got with a targeted mutation. So I think it's a very meaningful update and really looking forward to talking about the results of how those how those patients are doing when we get to ash.
Definitive flex combo arm that started.
Recently right there.
That started again before the FDA hold so any patients that were started if you. If you dose drug for sake of argument 24 hours before the hold came in you stayed on drug they the FDA didn't ask us to take people off drug. They just said don't put more on so we had already started putting patients on combination.
Therapy, yet as you can imagine investigators are really excited about combo therapy and monotherapy with this program.
And so anybody that was that was started the study shortly before the end the F. D. A told us to stop adding new ones was able to stay on study and we've got five of those patients that we're going to talk about at ash.
Great. That's really helpful and one last question. If you can provide any color like what are you seeing these new patients are.
Being more spaces of mutant patient are you seeing more fleet three mutant patient getting enrolled yeah. So I wouldn't be a little cautious about saying too much about the data before we get to ash.
Just say that look you know we are we are really excited about this program.
This is the first.
New target identified in AML and Mds.
In years and not only is it the newest target, but coincidentally, it's the largest target it looks like every patient or virtually every patient across the spectrum of AML and Mds over expresses that long isoform of Iraq for.
And at least half the population has a very heavy over expression of that of that kinase. So we expect that the excitement is going to continue as long as the data stay consistent.
Theory to lab to clinic that if you have lots of Iraq for long.
Monotherapy should be sufficient to knock it down and knock it down hard.
And if you have a little bit of Iraq for L. It still a driver of disease, it's simply not the only driver of disease those would be the patients that benefit from from combo therapy. So we're going to see that as we moved from theory to the lab. The data were really consistent and attractive now that we've doubled the dataset in our targeted population have.
We've been able to maintain that level of consistency in the data and should be should the excitement. He building not just as a company and among investors, but frankly, among physicians and patients. That's what we're eager to talk about when we get to ash.
Great. Thank you so much for taking the question.
Again, if you have a question. Please press Star then one.
The next question is from Lee Whatsapp with Cantor Fitzgerald. Please go ahead.
Hi, Thank you for taking my question a quick one on <unk>.
For the 11 additional enrolled patients by the time of the presentation.
And how many you'd be able to get a potential efficacy read on.
Little early.
Yeah. So we're gonna. Thank you Lee a first for the question, we're going to be talking about efficacy for all 11 patients. So we were going to be looking at and efficacy pool of 24 patients with a targeted mutation. So obviously, we consider this a significant and meaningful update.
And as I said, we're really excited about doing it and stay tuned.
Great. Thank you and then just one follow up.
Do you think you'd potentially be able to go back to the FDA with the new patient data and then discuss the next steps for anthem.
It's a great question so.
Let's let's step back in time, just as a reminder, when the FDA put us on hold in the spring.
They had three fundamental questions. The first one was there was a patient who died.
And they wanted to make sure that that wasn't an issue with the drag of the study in any way and then second they knew that we had an early signal it was rare, but but but a signal in CDK elevation in rhabdo. They wanted to make sure that wasn't a problem in the in the index patient and the patient death or in any other patients make sure that they didn't need to.
Our protocol in any way are we identifying and managing CPA elevation in Rhabdo appropriately and then third there.
They asked us about dose project optimists.
Which dose is the right dose taken a recommended phase two so we were able over the course of the summer. We said this in the beginning and I'm glad of course to be able to say now that it worked out that way. The FDA was going to get comfortable as we were as they learned more about the patient death.
That this is a patient with relapsed refractory AML, who had a life expectation of 2.3 months in the literature that patients died in month nine.
Our view would be that patient question shouldn't be why did the patients die.
Questions should be how did that patients get to month nine and the answers of course the drug.
The patient eventually did progress.
And the F D. A of course got comfortable with that as they reviewed more data.
The second question was on C. P K elevation in Rhabdo.
We do know it is rare to see it in our study, but we do see it we do know that our drug can exacerbate a C. P. K elevation in some patients. We do know that there are confounding factors and we were able to identify them in the data with F. D. A if you're on a statin if you're on a fiber eight if you're a heavy exerciser you will see C. P K elevation.
But we know exactly what to look for the protocol has really good.
Language for identifying it training the patients doing blood draws to see if there is a CPG elevation and the procedures are in the protocol for managing effectively and we didn't have any patients.
Have a have renal complication, which was obviously terrific. The F. D. A reviewed all of our procedures in all of our data and of course got comfortable with that as well. It was the last question on dose and this is really getting to answer your question directly that the F. D. A was able to focus on the most and we're involved most of the discussion.
In the context of project Optimus.
Where the F D a wants to know and be involved in.
Which dose moves forward and drug studies.
Emma who search of represents an ideal drug for that purpose.
We studied and cleared for safety purposes, 200 milligrams, 300 milligrams and 400 milligrams and all three dose levels got responses.
That's the perfect place for F D a to to want to sink their teeth and.
Now we came back.
Suggesting that between 304 hundred.
There was no efficacy increase.
But there was a risk that there might be some off target effect, we were saturating. The targeted 300. So it didn't make sense to go to 400 300 was better between those two between two.
203 hundred we feel as though when we run our exposure analysis, there's a higher probability of getting a response at 300 milligrams.
And therefore 300 is better than 200.
And the F. D. A said okay. We appreciate the logic that makes sense, we just like to see a few more patients at that lowest dose level to make sure we agree.
And so the negotiation with FDA was all about how many more patients do you need to be able to see to help us decide is 200 or 300, the appropriate recommended phase two dose.
And we agreed on the number nine.
So we're going to spend the next you know this this quarter of course now that were open for enrollment where the blocking and tackling is in process of getting all of our sites open and then of course, we're going to quickly move into enrolling those nine additional patients and my hope would be that.
So sometime early to mid next year, we've got those patients on study we can run the analyses on them build the briefing book and have that discussion with FDA and one of two outcomes is going to happen.
Either the data is going to come back exactly the way, we thought and the way. The early data suggested and three hundreds are dose and FDA will agree.
Or frankly, we were wrong and when we put nine more patients on at 200 milligrams, we get a bunch of Crs 200 milligrams in which case you know what the FDA turned out to be right or at least the question turned out to be valid and we will then move forward with 200 milligrams as our dose, but we should know that sometime by mid next year would be my.
Yes.
It was a really long answer, but I wanted to make sure to address it thoroughly did that help out.
Yes, I appreciate that very much. Thank you.
Okay. Thank you.
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.
Excellent. Thank you operator, and thank you everyone for today for joining today's call.
And as always thank you to the patients and families participating in our clinical trials.
To our team at curious 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 updating you again soon.
Thanks, Gary.
Thank you. The conference has now concluded. Thank you again for your participation you may now disconnect.
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Okay.
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