Curis Inc. Q1 2023 Earnings Call
Thanks Sheila.
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Good morning, and welcome to the curious first 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 an opportunity to ask questions to ask a question you May Press Star then one on your Touchtone phone.
And swept all your question. Please press Star then two please note. This event is being recorded I would now like to turn the conference over to MS. Diantha Duvall curious Chief Financial Officer. Mr. Matthias. Please go ahead.
Thank you and welcome to the curious first quarter 'twenty twenty-three 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 first quarter 2023 business update release and related financial.
Yeah.
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.
Bob Martell, Chief Scientific officer, and Jonathan <unk>, our newly appointed Chief Development Officer 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. Thank.
Thank you Dan and good.
Good afternoon, everyone and welcome to curious as first quarter business update call.
This past quarter, we made important progress with our lead clinical candidate and other certain.
As we mentioned in our March update we completed enrolling the additional patients requested by FDA ahead of schedule, which we believe is indicative of both the clear unmet need in leukemia and the excitement among the clinical community for this novel agent.
We are collecting and analyzing data from these patients this quarter and expect to discuss these data with the FDA in the third quarter.
We are optimistic that these data will be sufficient for the FDA to allow us to proceed with our recommended phase two dose and move into the expansion phase of our take game leukemia study.
We're also enrolling patients with primary central nervous system lymphoma, or P. C N S L.
And treating them with them it was sort of in combination with the beat TK inhibitor ibrutinib.
Our take game lymphoma study.
We believe mobile search it in combination with Ibrutinib.
Has the potential to be an important new therapy in P. C. N S. L, which is an orphan population of patients with high unmet need.
I'm also pleased to announce the expansion of the curious executive team with the addition of Dr. Jonathan <unk> as our Chief Development Officer.
Doctors on strengthens our executive team is a well respected industry leader with a wealth of drug development experience in both biotech and large pharma.
In short the curious team continues to make significant progress in establishing our lead clinical candidate <unk>, who started showing both clear single agent activity.
And broad potential in combination therapy as a potential cornerstone treatment in hematological malignancies.
And we look forward to sharing the results of our discussions with FDA in the quarter ahead.
With that I'll turn the call back over to Diantha to review our financial results for the quarter.
Panther.
Thank you Jim.
So the first quarter of 2023 terrorists reported a net loss of $11 6 million or 12 cents per share.
As compared to a net loss of $16 1 million or 18 cents per share for the same period in 2022.
Revenues for the first quarter of 2023, or 2.3 million as compared to $2 1 million for the same period in 2022.
Research and development expenses were $9 1 million for the first quarter of 2023 as compared to $11 4 million for the same period in 2022.
The decrease in research and development expenses for the quarter is primarily attributable to the timing of manufacturing costs and lower employee related costs due to due to a reduction in head count.
General and administrative expenses were $4 8 million for the first quarter of 2023 as compared to $5 7 million for the same period in 2022.
The decrease in general and administrative expenses was driven primarily by lower employee related costs due to a reduction in head count.
For the first quarter of 2023 other income net was <unk> 1 million as compared to other expense net of 1 million for the same period in 2022.
Other income expense net primarily consist of interest income, partially offset by expense related to future royalty payments.
As it.
As of March 30th 20, twenty-three curious as cash cash equivalents and investments totaled $71 8 million and there were approximately $96 6 million shares of common stock outstanding.
We continue to be in a strong cash position and expect that our cat 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 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 Touchtone phone if youre using a speakerphone. Please pick up your handset before pressing the keys and to withdraw your question. Please press Star then two and at this time, we'll pause momentarily to assemble our roster.
Yeah.
And our first question will come from Lee <unk> with Cantor Fitzgerald. Please go ahead.
Hey, good afternoon, thanks for taking our questions.
Jim just curious what the nine additional patients that you enroll in Q1.
Do you Havent done all the activity that you've seen so far compares to the higher doses 300, Meg and do you have plans to maybe share the data prior to your meeting with FDA in Q3.
So thank you very much for the question. So we're planning on having the discussion with FDA first and then we'll discuss the data more publicly later of course, that's the way the FDA would prefer it.
And I think that's the best answer for US at this time I think what we can tell you that we've said in the past.
Is.
We answered all of the Fda's questions last year with one exception.
And that was we've got two doses 200 milligrams B I D and 300 milligrams B I D. Both of which look safe both of which have shown responses and the open question with the F. D. A is which is the better of those two doses. So our view would be the data we had last year at this time.
Seem to anticipate.
Dissipate that both were good both could lead to responses. Both we're safe there seemed to be a slight preference for 300.
We have since added more patients at 200 to have a more fulsome analysis between the two.
And my assumption is going to be that when we take these data to the FDA, they're going to look at the dataset and come out where we're where we are and that is both doses are safe. Both doses are effective if there is a preference for 300 that means the data were completely consistent with what we've seen so far if there's a preference for 200 and that means.
The data at 200 look even better than they did last time either of those outcomes is good and I look forward to walking you through what these data look like after we have the conversation with FDA.
Okay, maybe a pretty long answers the question hope that's helpful. Yeah sure.
Maybe a follow up question. When do you think you might be able to communicate to the street with respect to the clinical hold after the meeting Q3, and I guess, what its meeting would you be able to discuss the registrational path with F D as well.
Yeah.
I think our plan right now is that we hope to have this discussion with the FDA at the end of Q3. So we're of course, we would come out with the answers but that is as soon as we have it that.
We're moving forward in terms of the next steps I think we've been pretty clear and in AML.
The design and the precedent for the design is fairly straightforward, we look at I D. H, one N D. H to flit three all of these studies pivotal studies were done with a single arm design.
With CR CRH as a primary endpoint.
Duration of response and survival of secondary endpoints.
And we would assume that going forward. The FDA is going to be consistent with their past practice and have a similar design.
And Mds, it's a longer discussion, it's both a good and bad thing.
The reason why it's a longer discussion is because there is no precedent for relapsed refractory treatment of MTS and that's precisely because there are no drugs approved.
So the the good news and that of course is that it's a wide open space.
The more you know uncertain news is of course, because it's a wide open space because nothing is approved it's going to take some dialogue with with FDA.
As with getting off clinical hold I look forward to having those discussions with FDA and of course the minute. We can we will be very eager to discuss with you.
Great. Thank you.
Hmm.
Again, if you have a question. Please press Star then one our next question will come from Yale Jen with Laidlaw <unk> Company. Please go ahead.
Good afternoon, and thanks for taking the question.
Thank you.
My first question is that with the nine patient you'll already road is there anything you can talk about the general characteristics of these patients.
So yeah, we're going to we're going to withhold talking about baseline characteristics or anything else that we're seeing until after we've had the discussion with FDA, we're not going to try and front run.
The FDA discussions.
What we can say is that what you already know.
In this population whether youre looking at relapsed refractory AML or relapsed refractory Mds. These patients all have a very poor prognosis median survival in the literature is anywhere from 2.3 to six months.
It's just a very bleak prognosis. So it is fair to say that any patients that have come into the study so far and any patients we're likely to see between now and NDA submission those are gonna be patients that are unfortunately in pretty tough shape.
Understood.
And I respect that as well.
Also my follow up question here is that you mentioned about E T N L.
Oh.
Could you give us a little bit background, how would you started and what was the rationale behind it and.
Where things are at this moment now and what do you anticipate in six or nine months and thanks.
Yeah.
Now for going into primary CNS lymphoma. So I can start and then I'll ask Bob to join and so in general in lymphoma, you remember, we're treating lymphoma in combination with Ibrutinib. The logic there is b.
B cell lymphoma.
Today, It is treated really to down regulate Nf Kappa b activity and Nf Kappa B inter.
It is driven by two biologic pathways.
The VCR pathway, where it be teekay lives and the toll like receptor pathway.
Iraq for less.
What we what we discovered in our early scientific work that was done corroborated in AR in the lab and then of course later in the clinic.
Is that if you want to down regulate Nf Kappa b activity in these patients.
First thing to do isn't to shut down one pathway or the other it's just shut down Paul So that's the logic behind going down lymphoma in general and in primary CNS lymphoma in particular.
This is a.
It's a type of cancer, where it's particularly sensitive to the toll like receptor side as opposed to the PCR side and it's an orphan drug indication. So it should mean that we can get to an answer fairly quickly there.
Hopefully it works in our favor and Bob I don't know if you want to add any more color to that yeah. No I think that was a good good explanation.
The E. The majority of patients who have primary CNS lymphoma have mid 88 mutations and is it sort of just to expand on what Jim said. This is a key driver of.
Iraq for and ultimately Nf Kappa B activity.
And so the.
The disease the P. C S L disease seems to be weighted more towards the <unk> pathway and.
In terms of whats.
What's driving the actual disease now we have some really interesting data and there's some nice data published in the literature in particular with CNS lymphoma.
For example, we know that in preclinical models, we get excellent exposure and we've asserted in these tumors and crossing the blood brain barrier as well. So this is a nice feature of asserted in fact getting levels. In these preclinical models that are at.
Therapeutics and therapeutic ranges.
That's been demonstrated not only for our CNS lymphoma, but actually just as an aside for melanoma as well.
So we think that this is a great area, where there's not a lot of other drugs approved or use and we think it's a great opportunity for us to cap.
Capture as a potential early indication.
Okay.
And what type of.
It takes it to be in terms of mix.
Nine months should that be something that the FDA meetings endo with.
Have a happy ending.
Yes, it's too premature to talk about the timing of when we're going to have those data just yet I would say at this point we are in the phase of working with our sites to identify the patients get them on drug and then we'll follow them.
You know just broadly.
One of the reasons why most investors have been following leukemia more than they've been following lymphoma.
Is that the.
Good news for the patients as the leukemia disease sets tend to be a much worst prognosis that patients frankly don't survive very long versus in lymphoma. Their outcomes are a little bit better. So our view would be it all things being equal we're likely to have datasets and the leukemia side sooner then we'll have datasets into law.
Former side, but we are moving fast and furious on both fronts simultaneously.
Okay. Thanks, a lot okay I'm sorry.
I'll quickly add to I don't know if you remember our data that we presented last.
Last year, we had one patient who was resistant to Ibrutinib, who continue to Bruton Ed. This is a patient with primary CNS lymphoma. They continue to Bruton have been added in the search of Ben and quickly went into a complete response.
We're really excited about that I think that's a nice proof of concept in pay in patients yeah underscores the idea as we said that Nf Kappa B is really driving the disease and in turn what's driving Nf Kappa B in these patients appears to be mitigate going through the toll like receptor side.
Which means they should be more amenable to our drug being added in combination in and to Bob's point.
That one patient was only one patient, but it's obviously very exciting that its consistent with what you might expand a nice proof of concept that we can overcome ibrutinib resistance exactly.
Okay great.
That's very encouraging and again, thanks, a lot and best of luck or the meetings with the agency.
Thank you Yale.
The next question will come from Dane Leone with Raymond James. Please go ahead.
Hey, guys. This is Sarah on for Dan I have two questions first how long is the follow up duration for the 200 milligram expansion cohort package can be taken to the F. D. A.
And then also.
Looking back at the Venice class a combination that you guys disclosed at Ash last year.
Are we gonna be seeing any follow up data Omar with heart rhythm patient characteristics are at any point this year. Thanks.
Sure. So let me address the first question first so in terms of the follow up Tom I think you can you can glean that from the guidance that we gave on timing so.
We opened the sites up in Q4, we recruited patients in Q1, we're following them and getting them to getting the data back in Q2.
And then we're filing in discussing data with FDA in Q3, So that's short of.
The timeline really in a nutshell.
Venetic clocks, you may remember that when we were put on partial hold.
The FDA asked us to.
Enroll only.
The monotherapy at 200 milligrams. So we don't really have further information to talk about in those combination patients although of course.
As you can imagine as we look forward to lifting of the partial hold we look forward to moving forward not just with monotherapy, but with a common combination therapy path and look forward to having those discussions with you as soon as we can and maybe I can add to that one of the exciting things about vanilla klaxon as you recall the data.
You know it looks like there is some really nice anti cancer activity there one of the key ways that.
Leukemias develop resistance to Panera classics is actually up regulation of other anti apoptotic factors such as Mcl, one Bcl Bcl XL.
And these have been shown to be regulated through this exact pathway and that's why we think.
No.
This drug and the search him.
Maybe able to overcome resistance of vanilla classes as well.
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, Mr. James Dentzer for closing remarks. Please go ahead.
Thank you.
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, <unk> and the NCI for their ongoing help 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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