Q1 2022 Curis Inc Earnings Call
Our AML.
And high risk Myelodysplastic syndromes or Mds.
Second the take a lymphoma study.
Our phase one two combination study with ibrutinib for patients with relapsed or refractory NHL and other hematologic malignancies.
And third the phase II Lucas study evaluating <unk> in patients with lower risk Mds.
Yeah.
In January we announced positive updated clinical data from the <unk> leukemia study showing early but compelling response rates in patients with spliceosome or flit three mutations.
These results demonstrated both a manageable safety profile and improved anticancer activity compared with the current standard of care.
Patients enrolling in this study are often in rough shape.
They tend to be heavily pretreated and have an expected median survival of less than six months.
Given that baseline we've been very encouraged by the study results to date.
We will be presenting the data highlighted in January at the <unk> and <unk> medical conferences in June .
Beyond that we expect to report updated data from the monotherapy and combination portions of the study later this year.
In April .
The FDA asked us to pause the enrollment of new patients, placing partial clinical holds on both the take in leukemia and take aim lymphoma trials. Following <unk> report to the FDA of the depth of a relapsed refractory AML patient.
Who after being on study drug for nine cycles.
Experienced among several other conditions rhabdomyolysis.
Patient safety is always our top priority, we are working with the FDA to provide additional data related to Rhabdomyolysis and also our recommendation of 300 milligrams PID as the recommended phase II dose.
And we hope to resolve the partial hold as quickly as possible.
We expect to provide updated guidance on the timing for discussions with FDA on a potential rapid registrational path for <unk>. After the partial clinical hold has been resolved and any potential impact on the study can be determined.
Now, let's turn to our study of <unk> in B cell cancers, the take game lymphoma study.
We expect to report initial data from this study at both <unk> and <unk> in June the same data at both meetings to address both the American and European audiences.
This update will include new data on approximately a dozen patients who have received <unk> in combination with ibrutinib in several types of NHL.
As a reminder.
A one of the study which has completed exam.
Examined dose escalation in monotherapy.
Part a to in process now is.
<unk> is exploring the combination of <unk> and Ibrutinib.
This combination study is expected to enroll approximately 18 patients in a three plus three design with.
With <unk> doses, starting at 200 and escalating the 300 milligrams PID.
And a bruton of dosing.
It will be whatever is appropriate for the patients respective NHL subtypes.
In this initial dataset, we'll be looking to confirm that the combination of <unk> and ibrutinib can be dosed safely without overlapping toxicities.
And of course, we also hope to see signs of anticancer activity.
Especially for patients relapsed or refractory to PTK inhibitors signs of anticancer activity would be in early and encouraging proof of concept for the scientific literature, which suggests that targeting both the <unk> and <unk> pathways.
May prove more effective than targeting either pathway alone.
I'd also like to comment briefly on our collaborations studying <unk> in patients with low risk Mds.
This study is being led by Dr. <unk> Bekker the co chairman of the European Hematology Association scientific working group on Mds.
We hope to report data on this study later in 2022.
Being able to demonstrate safety and efficacy in these patients could represent a potential breakthrough in the Mds field.
In March a new potential opportunity for Iraq for inhibition was identified with the publication of preclinical data in the peer reviewed journal Gastroenterology.
Authored by our collaborators at the Washington University School of Medicine in St. Louis.
This manuscript examines the role of Iraq for and the preclinical efficacy of <unk> in combination with checkpoint immunotherapy in pancreatic ductal adenocarcinoma.
A disease type with a very poor prognosis.
And in need of new therapeutic options.
As we look ahead, we hope to build upon these results working with the NCI and our other collaborators to identify additional new cancer targets, where <unk> could address areas of high unmet need.
Moving to our second asset.
$89 93.
This is the first in class monoclonal anti Vista antibody, which we are developing in collaboration with <unk> for the treatment of patients with relapsed or refractory solid tumors.
CA 80, 993 is designed to antagonize the Vista signaling pathway.
Thereby increasing T cell mediated immune function.
We believe Ci 80, 993 is the most advanced anti Vista antibody currently in clinical development and has the potential to be a game changing cancer therapy.
Affecting numerous cancer related immune mechanisms many of which are not addressed by targeting PD, one <unk> four or other immune checkpoints.
In January we presented updated clinical data.
Highlighting an encouraging safety profile and early signs of Ci $89 90, three's potential to activate multiple anticancer immune mechanisms.
We were additionally, pleased with the PK profile, which exhibits saturation kinetics, suggesting the potential to overcome the anticipated sink effect.
Dose escalation has proceeded to the 0.6 milligrams per kilogram dose level.
And we will continue until the recommended phase two dose has been determined.
We look forward to reporting expanded safety and Tolerability data along with initial PK PD and anti cancer data from the trial in the second half of 2022.
In summary.
We're pleased with the clinical results observed to death to date.
And we expect to provide several updates later this year include.
Including new clinical data in both Iraq for and Vista programs.
In the meantime, we will work with the FDA to resolve partial clinical holds as quickly as possible.
As we have said to many of you in calls over the last few weeks clinical development is never a straight road.
We're fortunate to be working with a molecule with the unique and compelling profile of <unk>.
With that I'll turn the call over to Bill to review our financial results for the quarter Bill.
Thank you Jim.
<unk> continues to execute on its strategy from a position of financial strength.
For the first quarter of 2022, <unk> reported a net loss.
$16 million or <unk> 18.
Per share on both a basic and diluted basis as compared to a net loss of $9 9 million or <unk> 11 per share on both a basic and diluted basis for the same period in 2021.
Revenues for the first quarters of 2022, and 2021 or $2 1 million and $2 2 million respectively.
Revenues for both period represent royalty revenues recorded on Genentech and Roche's net sales of <unk>.
Operating expenses for the first quarter of 2022 or.
Were $17 2 million.
As compared to $11 million.
For the same period in 2021.
Operating expenses comprise the following.
Cost of royalty revenues, which comprised of amounts due to third party University patent licenses in connection with royalties received on net sales of <unk>.
$1 million for the first quarter of 2022 and 2021.
Research and development expenses were $11 4 million.
For the first quarter of 2022 as compared to $6 8 million for the same period in 2021.
The increase was primarily attributable to increased manufacturing costs for our programs and higher personnel costs as a result of additional head count.
General and.
Administrative expenses were $5 7 million.
For the first quarter ended March 31, 2022, as compared to $4 1 million for the.
The same period.
'twenty one.
The increase in general and administrative expense was driven primarily by higher costs for personnel stock.
Stock based compensation.
Professional and consulting services and insurance as compared to the prior year.
Net other expense for the first quarter of 2022 and 2021.
It was $1 million and $1 1 million respectively.
Net other expense primarily consisted of imputed interest expense related to royalty payments.
As of March 31, 2022, <unk> cash cash equivalents and investments totaled $127 million.
And there were approximately 91 6 million shares of common stock outstanding.
First quarter cash burn was consistent with prior years of being higher than other quarters, driven by the timing of working capital changes.
We are in a strong cash position.
We continue to expect that our existing cash and investments should enable us to maintain our planned operations into 2024.
With that I'd like to open the call for questions operator.
Ladies and gentlemen at this time, we'll begin the question and answer session to ask a question you May Press Star and then one on a touchtone telephone.
Speaker phone, we do ask that you. Please pickup your handset before pressing the keys to ensure the best sound quality.
To withdraw your question you May press Star two.
Once again that is star and then one to join the question to you.
Our first question today comes from Lee <unk> from Cantor Fitzgerald. Please go ahead with your question.
Okay. Thanks for your update and thanks for taking my question.
I guess first one you mentioned that additional data requested by Andy.
The FDA I just wonder if you can talk a little bit more.
Need additional preclinical data or clinical data and do you need together.
Correct.
More clinical data find malware doses to follow.
Confidence issue.
Yes.
Let me address it this is Bob Martell.
We are obviously working closely with the FDA to answer their questions.
You know as Jim mentioned.
They had requested a variety of.
Components from US one of which was a little bit more information to help us and them untangle the complex patient, who unfortunately passed away.
During treatment and after several eight months actually of treatment with this drug another is.
Somewhat related to that and that is our work to identify the appropriate dose going forward. So we've mentioned in the past based on our Pharmacodynamic work, our pharmacokinetics safety and efficacy that we believe the 300 milligram twice daily dose is our recommended dose.
We'll present those data to the FDA and have a discussion with them regarding that.
Beyond that.
The specifics of the data.
We'll discuss that with the FDA and divulge more of that as we come to an agreement with them.
Okay can I ask a follow up question I guess.
The determination at the space sure Gary I guess.
You just talk about I guess, what additional data points at FBA E.
E TCE to Jakafi.
Delek.
Shen and I guess, what gives you confidence that you can resolve the code quickly.
Yes, so like I said, we've done a pretty thorough analysis and in fact as you know we've.
Evaluated a number of patients at 400 milligrams twice daily 300 milligrams twice daily as well as numerous other patients at lower dose levels. So part of the approach to.
Identifying a recommended dose is understanding the exposure of each individual patient and so.
And this is typical for any drug in any any development and more of what Theyre looking for these days is a good understanding of pharmacokinetic exposure bands. So we'll present those data to the agency.
To discuss that and justify our choice of 300 twice daily. In addition, we've carefully monitor the safety across all of these doses.
We believe that the <unk>.
Safety is a 300 milligram twice daily is a safe dose and will present our data.
Guarding that.
As I mentioned earlier, we will provide data to better untangle the complicated issues with this one particular patient who unfortunately passed away on the study.
So those are some of the main things that we'll be looking at and presenting to them and a full report.
Okay. Thank you very much.
Our next question comes from Sumit Roy from Jones Research. Please go ahead with your question.
Hi, everyone. Thank you for taking the question.
Wanted to just clarify one thing is.
Have you already submitted all of the net.
<unk> data set.
Set with FDA regarding this partial hold or do we have a timeline on that.
So again, we're working closely with the FDA.
Haven't given specifics on.
The timing of that or whether or not we haven't done that yet but.
As soon as we.
Gained further information on our discussion with the agency than oil.
We released that information.
Okay.
The June data in the in the on the AMOLED front Tom.
That will be.
No new data will be probably finer details you can provide would you also include.
And in mid year at <unk> would you also include details on this patient to.
Died.
During the presentation.
Yes, Thanks, Shannon So I'll do the first one first so the June data update and theres going to be.
Two updates right, there's going to be the leukemia and lymphoma leukemia is not an update that's the January 6th data.
As you May remember it was put out in our press release. This is now going to be at a peer reviewed forum. So it's our opportunity to get that in front of the global physician network at both <unk> American and European forums.
Lymphoma on the other hand is new data, that's going to be roughly a dozen patients of <unk> in combination with ibrutinib.
And so I would point you to that.
And then lastly, you asked whether we would take the opportunity at one of those two conferences to to discuss more about the patient death.
No.
Right now as having that dialogue with FDA and as Bob mentioned.
The patient was on for a long period of time, and we do have a lot of data related to that patient and I think the question is a fair one but it's of course, a complicated one as well and as we get resolution with the FDA on where they come out and where we can both.
Get comfortable moving forward that at that point of course, we are happy to share all of the details, but because this is sort of an ongoing discussion and a very complicated discussion we want to wait until we've got that resolved with FDA before we go public with the information.
Got it totally understandable and one last one.
On the lymphoma front.
Part two.
Would you present any data with 300 milligram B I D R.
Can you disclose any patient being treated with 300 milligram b I D or pretty much all 200 milligram.
Yes.
As I said I think we're going to wait for the disclosure of those data at that conference, but it is going to be new data and I would encourage you to keep an eye out for it we look forward to talking about it.
Thank you so much for taking the questions.
<unk>.
Our next question comes from Yale Jen from Laidlaw <unk> Company. Please go ahead with your question.
Good afternoon, and thanks for taking the questions.
I've got two here the first one is that.
Ed.
A partial clinical hold.
For the other study combined how many patients are still eligible.
0.2 to undergo couldnt undergo.
Under those studies.
On both a lymphoma and leukemia.
Well.
Want to make sure I understand your question so we.
Personal clinical hold had us pause enrollment of new patients all the patients who were existing on study who we felt we're benefiting from the study are allowed to continue on so it.
It did not prevent those patients who are ongoing from continuing.
We haven't we haven't mentioned the specific number who are ongoing but any patient.
Who is continuing on would be able to remain on hold.
<unk> is a.
Simply keeping us from adding new patients to the study so it really gets to the amount of patient data that we might have by year end, but the existing patients on study that are benefiting from the drug of course, they can stay on and.
Britain.
Okay, Great and maybe just two quick ones number one is that for.
For the pancreatic.
Okay.
Kansas study that.
Is that allowed at this point or you still being under the.
Partial clinical hold until that being resolved to start of enrollment.
So the <unk> study that's not part of these clinical studies, but as I would say.
Our approach you may remember when the leukemia study was originally put on hold since it's the molecule we were advising our partners.
Across the studies whoever's using the drug that the spirit of the FDA clinical hold was don't enroll new patients. So of course, we would give wash U the same advice.
We'd say look, let's let's wait till we get resolution with the FDA before we start enrolling new patients whether it's in one of our existing clinical studies or whether it's in them and in ISG. That's the same guidance, we would give to anybody using <unk>.
Okay, maybe the last one here little bit housekeeping debt given that.
You might have slowed down the console develop activity for a short while.
Anticipated R&D expenses at.
At least for the maybe next one or two quarters lower.
<unk> slightly lower before taking up.
Yes, well, let me, let me start that and then I'm going to hand over to bill on that yield so sure.
So first I'd say.
Obviously the.
The irony here is.
While you're on partial clinical hold you're spending less of course than you otherwise would.
And it really gets to the long term impact is how long are we going to be on clinical hold and that's an unknown question to be fair I mean, we can look to the prior studies as you know in AML.
There have been five other studies five other companies who have had their AML programs put on hold in the last three years four of those five.
We're in the last year.
All of those came off in roughly a one or two quarter timeframe.
We don't know since of course every drug is different and every FDA conversation is different we don't know that that definitely means that we are in that timeframe, but if you use that as a proxy you'd say, it's a bump in the road between now and NDA and it's not something that I would consider a material question from a cash burn perspective, it's more a question.
Of.
Executing against the goals, especially when it when we think about how many patients data, we're going to be able to accumulate.
The in this calendar year and of course in the in the rolling quarter view.
Bill would you like to comment a little more on potential impact.
Yes, I wouldn't want to necessarily give guidance, but I think in terms of our approaches as we certainly want to spend money wisely and while we are on hold or will be.
Considerate about but theres still a lot of work.
As you know it takes a long lead time. So that this is just a quarter or two delay that will be wanting to make sure that continues on so I would expect us to.
<unk> spending money wisely over these next few quarters.
Maybe there's some savings there, but I don't think there'll be a big impact to the trend.
Unless the holders.
Longer than we expect.
Okay, great. Thanks for the details.
Best of luck guys.
Got it thank you.
Once again, if you would like to ask a question. Please press star and then one to withdraw your question you May Press Star two.
Our next question comes from Dane Leone from Raymond James. Please go ahead with your question.
Hi, guys. This is Shawn on for Dan Thanks for taking the questions.
Just one from us kind of get an idea of what the scale and scope of the.
The second half readout for <unk>.
Obviously, you haven't said, how many patients you've enrolled.
And the studies, particularly in the <unk> combos.
But I'm just trying to get an idea of maybe broadly how.
How many are you confident in the number of patients that are currently on study such that you could have a significant readout later in the year irrespective of how long the clinical hold glass and then.
Additionally, do you expect to read out any more data say on heme recoveries.
Our efficacy in patients who are not flip through your slides at Dominion.
Yes.
Lot of questions.
I'll try and hit them, all and if I Miss one Sean please.
Let me know and I'm happy to go back to it so.
The scale and the scope.
What we're expecting for the year, obviously is very dependent on.
Where we ended up with the FDA in this discussion, but I would say in general our milestones are very much the same as they were with the exception of course of the timing of meeting with the FDA to talk about the pivotal study.
And that one's just unclear so let's go through those milestones again.
First half of 2022.
We're going to report initial data for <unk> in combination with Ibrutinib in NHL.
That was already of course, we started enrolling that a while back. So we've already had those patients will have about a dozen patients of data to report out and that'll be it <unk> entity as we announced today.
Second we will have updated data for <unk> in AML and Mds monotherapy.
Later this year again, the number of patients is going to vary depending upon when we can restart the clinical trial and then how much time the patients have in the study and whether those data are mature enough.
For a disclosure later this year and then in the back half of the year. We've got two separate updates initial efficacy data for Ci 80, 993% of Vista program.
And of course in the back half of the year the combination data of M. A assertive with Acer in van.
In AML and Mds you May remember, we started dosing patients in the back end.
And Q4 this past year. So we do have a handful of patients who are on drug before the clinical hold was put in place and then hopefully of course, if we can get the clinical hold lifted and we can start to enroll more patients in that study or in that.
Yes.
Regiment as well, we would like to give an update on those data so a lot of data coming.
Over the next six to nine months across both.
<unk> and Ci 80 993.
Okay.
Great. Thank you.
Thank you.
And ladies and gentlemen, im showing no additional questions I'd like to turn the floor back over to the management team for any closing remarks.
Thank you Jamie.
And thank you everyone for joining today's call and as always thank you to the patients and families participating in our clinical trials.
Our team at <unk> for their hard work and commitment and to our partners at origin <unk> and the NCI for their ongoing help and support we look forward to updating you again soon.
Operator.
Ladies and gentlemen, the conference has now concluded we do thank you for attending today's presentation.
May now disconnect your lines.