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| Statement |
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| The drug looks in almost 200 patients tested to have a really good safety profile |
| As you know we -- our first studies started in lymphoma and that's of course where our most recent data are as well and that's really compelling |
| So it's really exciting from our perspective, and I'm hopeful that we can keep that momentum going forward |
| All in all, a terrific year of progress in leukemia |
| For now having an ultra-orphan indication where we can go into the relapsed/refractory setting where there are no drugs approved that should offer a pretty compelling regulatory opportunity |
| The meetings we had with physicians at ASH were terrific, and we were especially pleased to have Dr |
| But if we can maintain in BTK experience patients, a 20% or higher CR rate in lymphoma, I think that we've got a very compelling data set to have a discussion with FDA |
| I think the data set was fantastic |
| That yields a lot of very attractive benefits from a development perspective, especially in conversations with regulatory authorities |
| And that is, we've got a drug that has a great safety profile, that really seems to add efficacy wherever we're testing it and may be able to provide benefit in areas like second-line PCNSL where there are no drugs approved |
| But a 20% CR/CRh rate in salvage-line therapy, for either FLT3 or spliceosome in leukemia, we think is very compelling |
| It provides unique and compelling anticancer activity |
| So you're exactly right, the opportunity in MDS looks terrific |
| Of course, our first three patients look better than that |
| So solid tumors is really exciting |
| But the idea that we have a drug that looks as though it could provide incremental benefit that no other drug does in these very targeted markets individually and of course at the high level across the world of human solid tumors is really quite exciting |
| So if we can go after a disease that ultra-orphan, where there are no approved treatments, and we can see this kind of response from the drug, it's really encouraging |
| So we've got a great track record |
| Second has a compelling and unique efficacy profile, so that we can provide a measure of efficacy that you can't get from other drugs |
| That we're getting three out of five so far is obviously highly encouraging |
| But at this point in time, obviously, we're really excited that we're going to have the opportunity to get data across lymphoma, leukemia and now solid tumors and we can afford to do it |
| However, the response and interest from the clinical community was very encouraging |
| This looks to be a really compelling drug, and Curis is not the only company that's recognized that |
| As a result, we were able to confirm the safety profile of emavusertib, gain alignment on the optimal dosing regimen for monotherapy and secure the removal of the partial clinical hold, a full quarter earlier than expected |
| The data in lymphoma in the targeted population that we would expect to hit in the IRAK4 or spliceosome population and the FLT3 population those data look really compelling |
| So really this should provide incremental benefit from a new mechanism that no other drug does |
| And I think, frankly, our odds are pretty good at that |
| In short, we had an incredibly productive 2023, and we look forward to continuing that momentum in 2024 |
| In fact, it was quite a bit better than we would need |
| This significantly increases the efficacy of that standard of care treatment |
| Statement |
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| Entering 2023, the whole biotech industry was struggling in the headwinds of a green financial market |
| Curis faced all of that and the daunting challenge of seeing our leukemia study stalled on partial clinical hold with the FDA |
| In the face of that adversity, the Curis team rose to the challenge |
| Because remember, all of our patients have failed ibrutinib |
| However, as we said, half of all patients that go on to aza-ven have difficulty tolerating it |
| For the fourth quarter of 2023, Curis reported a net loss of $11.7 million or $2.03 per share as compared to a net loss of $11.3 million or $2.35 per share for the same period in 2022 |
| But let's not get ahead of ourselves |
| In the case of lymphoma, the problem driving disease for patients with NHL is NF-kappaB overactivity |
| Aza and ven, as you know, are a pretty tough regimen to tolerate |
| Curis reported a net loss of $47.4 million or $8.96 per share for the 12 months ended December 31, 2023 as compared to a net loss of $56.7 million or $12.14 per share for the same period in 2022 |
| We are cognizant that the doublet of Aza/Ven is difficult for patients to tolerate |
| Anecdotally half of all patients that go on that aza-ven doublet, have to discontinue treatment |
| So that's why we're going down that path |
| I couldn't be more proud of them |
| The more complicated answer is we don't want that to slow down our path to development and making this drug available for patients |
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