Norfolk Southern Q1 2023 Earnings Call Transcript

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May 4, 2023

There are 7 speakers on the call.

Operator

Good morning, and welcome to the Curis First Quarter 2023 Business Update Call. All participants will be in a listen only mode. After the company's prepared remarks, call participants will have an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over Ms.

Operator

Diantha Duvall, Curis' Chief Financial Officer. Ms. Diantha, please go ahead.

Speaker 1

Thank you, and welcome to the Curis First 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.curis.com to find our Q1 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.

Speaker 1

Joining me on today's call are Jim Dentzer, President and Chief Executive Officer Bob Martell, Chief Scientific Officer and Jonathan Zum, our newly appointed Chief Development Officer. 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.

Speaker 2

Thank you, Deanna. Good afternoon, everyone, and welcome to Curis' Q1 business update call. This past quarter, we made important progress with our lead clinical candidate, emavusertib. 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 Q3.

Speaker 2

We are optimistic that these data will be sufficient for the FDA to allow us to proceed with a recommended Phase 2 dose and move into the expansion phase of our TAKING leukemia study. We're also enrolling patients with primary central nervous system lymphoma or PCSLL and treating them with emabusertib in combination with the BTK inhibitor, ibrutinib, in our TAKAIM lymphoma study. We believe emabusertib in combination with Ibrutinib has the potential to be an important new therapy in PCNSL, which is an orphan population of patients with high unmet need. I'm also pleased to announce the expansion of the Curis executive team with the addition of Doctor. Jonathan Zung as our Chief Development Officer.

Speaker 2

Doctor. Zung strengthens our executive team as a well respected industry leader with a wealth of drug development experience in both biotech and large pharma. In short, The Curis team continues to make significant progress in establishing our lead clinical candidate emavosertib, 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.

Speaker 2

Diantha?

Speaker 1

Thank you, Jim. For the Q1 of 2023, Curis reported a net loss of $11,600,000 or $0.12 per share as compared to a net loss of 16,100,000

Speaker 2

or $0.18 per share for the

Speaker 1

same period in 2022. Revenues for the Q1 of 2023 were $2,300,000 as compared to $2,100,000 for the same period in 2022. Research and development expenses were 9,100,000 for the Q1 of 2023 as compared to $11,400,000 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 a reduction in headcount. General and administrative expenses were 4,800,000 for the Q1 of 2023 as compared to $5,700,000 for the same period in 2022.

Speaker 1

The decrease in general and administrative expenses was driven primarily by lower employee related costs due to a reduction in headcount. For the Q1 of 2023, other income net was $100,000 as compared to other expense net of $1,000,000 for the same period in 2022. Other income expense, net primarily consists of interest income, partially offset by expense related to future royalty payments. As of March 30, 2023, Curis' cash, cash equivalents and investments totaled $71,800,000 and there were approximately 96,600,000 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 2025.

Speaker 1

With that, I'd like to turn the call open the call for questions. Operator?

Operator

We will now begin the question and answer session. And our first question will come from Leigh Wasek with Cantor Fitzgerald. Please go ahead.

Speaker 3

Hey, good afternoon. Thanks for taking our questions. Jim, just curious for the 9 additional patients that you enrolled in Q1, do you have a sense All the activity that you've seen so far compares to the higher dose of 300 mg? And do you have plans To maybe share the data prior to our meeting with FDA in Q3.

Speaker 2

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.

Speaker 2

And that was, we've got 2 doses, 200 milligrams BID and 300 milligrams BID, both of which look safe, both of which have shown responses. And the open question with the FDA 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 that both were good, both could lead to responses, both were 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 2.

Speaker 2

And my assumption is going to be that when we take these data to the FDA, they're going to look at

Speaker 4

the data set and come

Speaker 2

out where we are and that is both doses are safe, both doses are effective. If there's 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, 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.

Speaker 5

Okay. Maybe

Speaker 3

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 for this meeting, would you be able to discuss Traditional path with FDA as well?

Speaker 2

Yes. I think our plan right now is that we hope to have this discussion with the FDA at the end of Q3. So, of course, we would come out with the answer with that as soon as we have it, that we're moving forward. In terms of the next Steps, I think we've been pretty clear in AML, the design and the precedent for the design is fairly straightforward. We look at IDH1, IDH2, FLT3, all of these studies, pivotal studies, were done with a single arm design With CRH as a primary endpoint, duration of response and survival as secondary endpoints.

Speaker 2

And we would assume that going forward, The FDA is going to be consistent with their past practice and have a similar design. In MDS, it's a longer discussion. It's both in a good and bad thing. The reason why it's a longer discussion is because there is no precedent for relapsed refractory treatment of MDS. And that's precisely because there are no drugs approved.

Speaker 2

So the good news in that, of course, is that it's a wide open space. The more uncertain news is of course because it's a wide open space and because nothing is approved, it's going to take some dialogue 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.

Speaker 3

Great. Thank

Operator

Our next question will come from Yale Jen with Laidlaw and Company. Please go ahead.

Speaker 6

Good afternoon, and thanks for taking the question. Thank you. With the 9 patient you already enrolled, is there anything you can talk about the general characteristics of these patients?

Speaker 2

So, yes, we're going to withhold talking about baseline characteristics and 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. But what we can say is that What you already know, in this population, whether you're 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 6 months. It's just a very bleak prognosis. So it's 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 going to be patients that are unfortunately in pretty tough shape.

Speaker 6

Understood. I appreciate that and I respect that as well. You may also my follow-up question here is that you mentioned about TCN test L and could you give us a little bit background How would you start it and what was the rationale behind it and where things are at this moment and what to anticipate in 6 or 9 months. Thanks.

Speaker 2

Yes. So the rationale for going into primary CNS lymphoma. So I can start and then I'll ask Rob, to join in. So in general, in lymphoma, you remember we're treating lymphoma in combination with Ibrutinib. The logic there is B cell lymphoma today is treated really to down regulate NF kappa B activity.

Speaker 2

And NF kappa B in turn Is driven by 2 biologic pathways. The BCR pathway, where BTK lives and the toll like receptor pathway, where iRAC4 lives. What we discovered in our early scientific work that was then corroborated 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, The best thing to do isn't to shut down one pathway or the other, it's to shut down both. So that's the logic behind going down lymphoma in general. And in primary CNS lymphoma in particular, this is a type of cancer where it's particularly sensitive to the toll like receptor side as opposed to the BCR side and it's an orphan drug indication.

Speaker 2

So it should mean that we can get to an answer fairly quickly, that hopefully works in our favor. Bob, I don't know if you want to

Speaker 4

add any more color to that. Yes. No, I think that was a good explanation. The majority of patients who have primary CNS lymphoma have mid-eighty eight mutations. And it's sort of just to expand on what Jim said, This is a key driver of, iRAC4 and ultimately NF kappaB activity.

Speaker 4

And so the disease, the PCNSL disease seems to be weighted more towards the TLR pathway, in terms of 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 of emobusertib in these tumors and crossing the blood brain barrier as well. So this is a nice feature of emobusertib, In fact, getting levels in these preclinical models that are at therapeutic ranges. That's been demonstrated not only for CNS lymphoma, but actually just as an aside for melanoma as well.

Speaker 4

So we think that this is a great area where there's not a lot of other drugs approved or used and we think it's a great opportunity for us to Capture as a potential early indication.

Speaker 6

And what type of Expectation to be in terms of next 6 to 9 months, should that be something occur after the FDA meetings and with So the happy ending is

Speaker 2

Yes. I think it's all too premature to talk about the timing of when we're going to have those data just yet. I'd 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. Just broadly, One of the reasons why most investors have been following leukemia more than they've been following lymphoma is The bad news for the patients is that the leukemia disease sets tend to be a much worse prognosis. The patients frankly don't survive very long versus in lymphoma, their outcomes are a little bit better.

Speaker 2

So our view would be all things being equal, we're likely to have data sets in the leukemia side sooner than we'll have data sets in the lymphoma side, but we are moving fast and furious on both fronts simultaneously.

Speaker 6

Okay. Thanks, Laura. Okay. I'm sorry. Go ahead, Steve.

Speaker 4

I'll quickly add to, I don't know if you remember our data that we presented last We had one patient who was resistant to ibrutinib, who continued ibrutinib. This is a patient with primary CNS lymphoma. They continued ibrutinib and added emavusertib and quickly went into a complete response. We're really excited about that. I think that's a nice proof of concept in patients.

Speaker 2

Yes. 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 mitigated going through the toll like receptor side, which means they should be more amenable to our drug being added in combination. And to Bob's point, that one patient was Only one patient, but it's obviously very exciting that it's consistent with what you might expect. Yes.

Speaker 2

And a

Speaker 4

nice proof of concept that we can overcome ibrutinib resistance. Exactly.

Speaker 6

Okay, great. That's very encouraging. And again, thanks a lot and best of luck for the meetings with the agency.

Speaker 2

Thank you, Yale.

Operator

The next question will come from Dane Leone with Raymond James. Please go ahead.

Speaker 5

Hi, guys. This is Laura on for Dane. I have two questions. First, how long is the follow-up duration For the 200 milligram expansion cohort package to be taken to the FDA. And then also Looking back at the venous collection combination that you guys disclosed at ASH last year, are we going to be seeing any follow-up data or more robust patient characteristics at any point this year?

Speaker 5

Thanks.

Speaker 2

Sure. So let me address the first question first. So in terms of the follow-up time, I think you can glean that from the guidance that we gave on timing. So We opened the sites up in Q4. We recruited the patients in Q1.

Speaker 2

We're following them and getting them the getting the data back in Q2. And then we're filing and discussing data with FDA in Q3. So that's Short of the timeline really in a nutshell. On venetoclax, 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.

Speaker 2

Although, of course, As you can imagine, as we look forward to listing of the partial hold, we look forward to moving forward not just with monotherapy, but with a common combination And look forward to having those discussions with you as soon as we can.

Speaker 4

Yes. And maybe I can add to that. One of the exciting things About venetoclax and as you recall the data, it looks like there was some really nice anti cancer activity there. One of the key ways that Leukemia has developed resistance to venetoclax is actually up regulation of other anti apoptotic factors such as MCL-one, BCL XL, and these have been shown Be regulated through this exact pathway and that's why we think this drug emilversertib may be able to overcome resistance of venetoclax as well.

Speaker 5

Great. Thank you.

Operator

This concludes our question and answer session. I would like to turn the conference back over to the company's President and Chief Executive Mr. James Denzer for closing remarks. Please go ahead.

Speaker 2

Thank you. And as always, thank you to the patients and families participating in our clinical trials, To our team at Curis for their hard work and commitment and to our partners at Aurigene, ImmunEXT and the NCI for their ongoing help and support. We look forward to updating you again soon.

Operator

Operator? The conference has now concluded. Thank you again for your participation. You may now disconnect.

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