Q2 2023 Curis Inc Earnings Call
Good afternoon, and welcome to the curious as second quarter 2023 business update call. All participants will be in a listen only mode should you need assistance. Please signal conference specialist by pressing the star key followed by zero. After the company's prepared remarks call participants will have the opportunity to ask a question to ask a question you May Press Star then one on your Touchtone phone.
One it's withdraw your question. Please press Star then two.
Please note. This event is being recorded I would now like to turn the conference over to Diantha Duvall curious as Chief Financial Officer Ms. Diantha. Please go ahead.
Thank you and welcome to the Coeur took care of the second 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 terrorists dot com to find our second quarter 2023 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 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 Jonathan.
Chief Development Officer, we will also be available for a question and answer period at the end of our call.
Now like to turn the call over to Jeff.
Thank you Dan.
Good afternoon, everyone and welcome to curious as second quarter business update call.
The Big news this quarter is of course, the removal of the partial clinical hold on our taking leukemia study and getting that done a full quarter faster than we expected.
It's a testament to the hard work of our team are curious and the strong support of our clinical investigators.
Like to take this moment to express my gratitude and appreciation to everyone involved.
In our discussions with FDA. We were also able to confirm that 300 milligrams B I D is the recommended phase two dose for monotherapy and leukemia.
With that confirmation, we're excited to announce that we're expanding monotherapy enrollment in the taking leukemia study at 300 milligrams B I D.
For relapsed refractory patients with spliceosome or <unk> three mutation.
In addition.
We're working with our clinical investigators on a frontline study.
Binding them are assertive with ease of siding and vanilla o'clock to treat all patients with AML, regardless of their mutation status.
We expect to have data from both the monotherapy and combination studies in 2024.
Now, let's transition to our two game lymphoma study, where we're focusing on patients with primary CNS lymphoma.
There's a high unmet need in this patient population and we believe combining them or who started with ibrutinib could potentially address the problem of ibrutinib resistance and provide a meaningful new therapeutic option for these patients.
We're currently enrolling patients and expect to have data in 2024.
On the financial front.
We were able to further strengthen our balance sheet with a $15 million equity financing achieved with no discount.
And no warrant coverage.
I'm sure everyone on this call knows how rare this is in the current market.
All in all it was a terrific quarter for curious and we're excited to be back in the clinic at the recommended phase two dose of 300 milligrams and closely collaborating with our clinical investigators to develop a novel therapeutic with the potential to be a cornerstone therapy in heme malignancies.
With that I'll turn the call back over to data to review our financial results for the quarter.
Thank you Jim.
<unk> reported a net loss of $12 million or 12 cents per share as compared to a net loss of $15 $9 million or <unk> 17 per share for the same period in 2022.
Curious reported a net loss of $23 $5 million or 24 cents per share for the six months ended June 30 of 2023 as compared to a net loss of $32 million or <unk> 35 cents per share for the same period in 2022.
Revenues for the second quarter of 2023, or two $2.2 million as compared to $2 $4 million for the same period in 'twenty two.
Revenues for the six months ended June 30th 'twenty, 'twenty, three and 'twenty 2022 were both $4 $5 million.
Research and development expenses were $10 million for the second quarter of 2023 as compared to $12 $3 million for the same period in 2022.
The decrease in research and development expenses for the quarter is primarily attributable to a decrease in personnel costs.
Research and development expenses were at $19 $2 million for the six months ended June 30th 2023.
As compared to $23 8 million for the same period in 2022.
General and administrative expenses were $4 $2 million for the second quarter of 2023 as compared to $5 1 million excuse me as compared to $5 $1 million for the same period in 2022.
The decrease in general and administrative expenses was driven primarily by a decrease in personnel costs.
General and administrative expenses were $9 million for the six months ended June 32023, as compared to $10 $8 million for the same period in 2022.
For the second quarter of 2023 other income net was point $2 million as compared to other expense net of <unk> 9 million for the same period in 2022.
Other income net.
Well, it's <unk> 2 million for the six months ended June 32023, as compared to other expense net of $1 9 million for the same period in 'twenty two.
Other income and expense net primarily consists of interest income, partially offset by expense related to future royalty payments.
Including the proceeds from the July financing curious as cash cash equivalents and investments totaled $77 $4 million.
And there were approximately.
$117 7 million shares of common stock outstanding.
We continue to be in a strong cash position and expect that our existing cash cash equivalents and investments should enable us to maintain our planned operations into 'twenty five.
With that I'd like to turn the call.
Over for questions operator.
Thank you we will now begin the question and answer session to ask a question you May Press Star then one on your Touchtone phone, if you're using a speakerphone. Please pick up your handset before pressing the keys.
Anytime Youre question has been addressed and you would like to withdraw your question. Please press Star then two.
And at this time, we'll pause momentarily to assemble our roster.
Okay.
And the first question will come from Sumit Roy with Jones trading. Please go ahead.
Hi, good afternoon, everyone and congratulations on all the progress through the solid quarter.
Thank you chairman.
Would love to get a little bit of color on how the conversations with the FDA went and.
Where they got back to confidence in putting the 300 milligram B I D to B the go forward dose.
Sure happy to so it really went to exactly the way we were hoping it would go it just went faster.
What we said when we were originally put on hold as you know.
The first questions. They had were about the patient deaths are 15 months ago. They very quickly came to the same conclusion, we did that that was due to underlying disease not to drug and then we immediately flipped into a project Optimus discussion and that's why it's been.
Over a year of work.
Their view was that they liked the decision process that we had made of testing the three doses 203 hundred and 400. They agreed all three doses were safe and all three doses lead to a response sort of a high class headache.
And while they liked 300 better than 400 for just the reason we said it looked like we were getting the same responses in both levels.
At 200 their view was we didn't have enough patients tested so all they really asked was put more patients on drug and as you know they asked for nine more so putting more patients on drug.
Run the data rerun the analysis and let us know if you'd come out in the same place and and the answer was really quite straightforward. We did exactly what they asked we put nine more patients on drug we compiled the data produced the report sent it off to F. D. A and it was really a very straightforward discussion 200 is it is a good dose it's an active dose but 300.
It looks to be a little bit better. So I'm pleased it came out.
And where we expected it would come out.
And obviously I'm very pleased that the FDA moved more quickly than we anticipated.
But this is a really good news yeah.
000, how when is the next data update at least from the 200 milligram are the longer term or should be.
I think that it's all going to be mid to later half of 2024 with 300 milligram and the combination trial.
Yeah, we were a little hesitant to commit to exactly which date, we're going to have data.
As you know in the in the update we gave in the press release, we said 2024.
As a matter as we go to every major medical conference in heat.
So where we're always out there talking to our investigators and and two analysts of course, and we want to get data out as fast as you want to see it.
So that the.
The issue for us on our end is now that we know are doses 300 milligrams.
Got to get the sites up and running and enrolling as fast as we possibly can.
So it seems like in this early stage. It was too early to commit to we're definitely going to have data by year end. That's why we said 'twenty 'twenty, four but which conference in 'twenty 'twenty four remains to be seen.
And you know, we'll get hopefully give an update on that later this quarter as we have a better eye towards enrollment.
Got it no that's that's totally understandable.
And on the combination trial with Vantiv black so in the frontline setting.
I'm, assuming you would continue to genotype patients and.
And I'm a holder of record the patients have direct full mutations with three in the other mutations and so.
And show the detail in the following subgroups if need be.
Yeah. So we're we're continue to look at those data and learn more about that in that population as you know or as we have made more public.
We now have a very clear strategy going forward as a result of our discussions with FDA.
We know that this drug very consistently.
From mechanism of action.
Preclinical data to clinical data it works exactly where we would expect at what is the single agent.
It works in patients.
With flit three of spliceosome mutation and so that's what we're going for monotherapy, but you'll also remember that Iraq for long as not just the single largest genetic driver of disease in this AML M. D S spectrum.
But it's also over expressed in the entire population half. The population has so much of it that monotherapy works.
The other half still has a significant amount.
It's just not quite as much as the monotherapy crap. So what we're planning on doing with this drug is in the rifle shot genetic populations, where this drug ought to be differentially active and so far it looks to be we're gonna go single agent relapsed refractory setting.
Again, with three and spices out for everybody else. We're gonna go frontline combination because we think that that's what makes sense in AML. The standard of care is as event.
So we're going to go as it then frontline in combination with Emerald research at all comers doesn't matter what mutation you have.
N M D S with the recent macro release from Gilead.
I would say the standard of care question is a little more open.
We're still waiting for the the output of these events study.
But it's not clear exactly what that standard of care regimen is so it's also not clear what we would want to add emmalou search it to so we at this point, what we're doing is engaging our physicians and kols to try and figure out what is the most appropriate strategy for this drug but long term. Our view generically is this drug is going to get used as a single.
Wherever it makes sense.
That's gonna be spices someone for three mutation.
And everywhere else, it's gonna go frontline all comers.
No filter needed.
That was a really long answer I hope that was helpful.
No that was incredibly yep. Thank you. Thank you again for taking the questions and congratulations.
Thank you I really appreciate it thank you for calling in.
The next question will come from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Good afternoon, and I'll add my congrats on the progress.
Thank you.
My first question is in terms of.
Hum in 12 months.
E L.
Could you give a little bit more color in terms of the current study.
Study design.
Dean.
Our process.
Process and.
Eventually.
But the timeline in terms of data release and call.
So it would be very helpful.
Sure. So in primary CNS lymphoma, so lets back step back for a second and just as in AML and Mds.
Iraq for is important.
Because it binds really hard to the medicine and <unk> 88 in particular.
In the toll like receptor pathway and shuts it down.
That's important in the AML Mds side, because Iraq for long is that the largest genetic driver of disease on the lymphoma side, it's an indirect target.
Shoot Nf Kappa B is the problem in primary CNS lymphoma, and NHL more broadly.
The current treatment is ibrutinib.
That shuts down the VCR pathway, which is one of two pathways driving Nf Kappa B.
Our drug <unk> search it shuts down the toll like receptor path, which is the other pathway driving Nf Kappa B.
So our strategy in lymphoma is.
These patients who really want to down regulate Nf Kappa b over activity.
Today, Theyre looking at using Ibrutinib or a PTK inhibitor to do that work.
We've got a drug that could be seen as an alternative in fact, we tested it as a single agent, but rather than to pick one Nf Kappa b down regulator versus another we found that they work synergistically. So what we're looking to do is find those indications with in NHL.
Where the disease is sufficiently aggressive that we can get an answer quickly.
Where the unmet need is critical.
These patients really don't have very good options.
And ideally where it's an it's an orphan sized indication.
Where we can get a very attractive regulatory path, while all three of those boxes get checked with primary CNS lymphoma.
Our our mechanism of action supports that that's a great indication for a great setting for this combination our preclinical data of course backed that up and there are early treatment are early days in the clinic showed that not only is that true, but it looks like small and we may be able to address.
Ibrutinib resistance, which is a particular problem.
In P C N S.
It's a problem in NHL more broadly, but it is a particular problem in primary CNS lymphoma.
So that's where we're headed it's going to be the combination of Ibrutinib plus Emma who started in the orphan indication of primary CNS lymphoma.
So that will be posed.
Rooted in our team in and what are you what's the size of the study initially you are planning.
What.
And while you are thinking.
That's right. So it's post its post ibrutinib.
So these patients.
In general Ibrutinib can give nice responses as you know in NHL oftentimes ibrutinib can get to a partial response it doesn't it doesn't very often get a complete response, but it but it can really help patients for a period of time, but typically these patients all relapse.
We're going to capture them at that point.
And then add them up with searches to the therapy.
Hope to regain.
That response that they had once had and hopefully deepen it so.
So that's the plan.
Got a small number of patients to date that we've reported out our goal is to try and get to 20 patients.
We can get 20 patients of data and we can show that again.
Reasonable sized population, but still small but it looks like this is a compelling.
Therapy that it it looks to be something that's.
A good option for these patients patients that have relapsed on Ibrutinib, we would want to go to the F. D. A to have a discussion about what the pivotal design needs to look like at that point.
So look for look for in any course 'twenty.
Our goal for this study.
So would you anticipate.
More of the PR or actually maybe some.
And where do you see or how should we overall think people fall in terms of the threshold you've built that said.
Worth to discuss with you.
Yeah, so what we'd be looking for is a couple of things first obviously it would be great to have a higher or are.
It would be great with in the responses.
To have more of those prs become Crs.
And then lastly, we'd be looking at duration.
In this group because they will have already relapse on ibrutinib any of those outcomes is a positive outcome and of course, we'll be examining those data very closely.
Okay, Great that's very helpful and congrats.
<unk>.
Starting this fall in both sides.
The email.
Cancers and Oh.
We look forward.
In the future.
Thank you very much and I appreciate your support thank you for calling in.
The next question will come from Lee <unk> with Cantor Fitzgerald. Please go ahead.
Yes.
Hi, This is Mary on for Lee Firstly, congrats on a great quarter again.
Thank you Jeff.
A couple of questions from us. So I know your last update was fairly recently and you mentioned that you've got the sites are up and up and running.
300 make those do you by chance happen to have a sense of enrolment speed, yet or maybe how long it would take you to reach your end of 'twenty.
Yeah, we really don't yet.
Obviously, we heard from the FDA.
We're excited about it and now we have to go back to the sites and we have to get back through their <unk> and then it's a lot of blocking and tackling at the at the clinical site to get the enrollment up and running so it's a little early to be able to say that they're all up and running again.
I think.
We're trying to do two things simultaneously from an operational perspective the.
The first one is we want to increase the number of sites as you May remember, we had nine sites at the beginning of the year, we'd love to end the year with double that.
So we're working with the with new sites identifying new Kols and trying to see if we can expand our network of clinical sites period.
With all sites, we're trying to get them up and running as fast as possible identify the patients screen them and then enroll them into the study my hope is that by the end of Q3, we'll have a pretty good sense of winter, where our enrollment rate is going and where our process of getting new sites up and running is going so we can.
Be a little more granular on which of the medical conferences makes the most sense for a data update at this point in time, we're obviously very confident it would be sometime in 2024, but we can't really get more granular until we have a better sense of what where enrollment is headed.
Sure sure. Thank you.
Yep. So on what are the data you already have at the RP Judy can.
Can you remind us about the bar for success for both flip we knew that installation on mutated patients and I don't know if this changes with the recent approval of.
In first line.
Yeah. So.
I would say.
First are our most recent data is in our corporate presentation on our website. So for you and for everybody else. That's on the call I would encourage you to go to curious dot com.
And if you scroll down you'll see our corporate presentation deck, you can open it up and we have the most recent data there and I think it's pretty compelling.
We've got data on 84 patients, which includes all comers all dose levels, but we also show the rightful shot of now that we know are patient populations.
Thats AML patients with spliceosome mutation in AML patients with <unk> mutation, that's going to be the population. We go after with monotherapy.
And we know our dose we know it is 300 milligrams.
We've highlighted on in that deck.
On slide exactly how many patients have had that combination and what they look like so what we're looking to do right. Now is we've got three patients.
At 300 milligrams, one or two prior lines, which is the group were looking for with a spliceosome mutation and three.
With a flip three mutation.
Of the three with a spliceosome mutation two of the three have a CR or CRH.
And of the three patients two of the three have a CR.
Now I'm not suggesting that we're going to get a 66% CR rate that would be outrageous that that's not what they get frontline what.
What I am suggesting.
Is that our goal in each of these population groups.
Is and equals 20.
What you really need in order to have a good discussion with FDA that you've got a single agent that shows compelling activity.
We probably need.
Four or five Crs CRH is in those groups to have a have a nice discussion.
So in each of these groups have an equal three.
We've got two or three so far.
We need two or three more in the next 17 patients in each of those groups.
And if we can get that then we can make a pretty compelling case that this novel therapeutic does seem to offer a.
Compelling benefit worth discussion.
Got it understood. Thank you so much and congrats again thank.
Thank you very much I appreciate it thank you for your support.
Okay.
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, Mr. James Dentzer for any closing remarks. Please go ahead Sir.
Thank you operator, 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 of tourists for their hard work and commitment.
Our partners at origin, <unk> and the NCI for their ongoing collaboration and support.
We look forward to updating you again soon.
Operator.
The conference has now concluded. Thank you again for your participation you may now disconnect.
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