Release Date: August 01, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Curis Inc (CRIS, Financial) reported an objective response rate over 50% in their TakeAim Lymphoma study, indicating promising results for emavusertib in combination with ibrutinib.
- Emavusertib has been granted orphan drug designation for primary CNS lymphoma by the European Commission, providing benefits such as 10 years of market exclusivity.
- The company is making progress in expanding clinical sites, aiming for 30 sites in the US and Europe by year-end.
- Curis Inc (CRIS) is exploring a novel mechanism for emavusertib in treating relapsed/refractory AML, with positive responses in patients with splicing factor and FLT3 mutations.
- The company has initiated a study of emavusertib in combination with azacitidine and venetoclax in frontline AML, with initial safety data expected later this year.
Negative Points
- Curis Inc (CRIS) reported a net loss of $11.8 million for the second quarter of 2024, slightly less than the $12 million loss in the same period in 2023.
- Research and development expenses increased to $10.3 million in Q2 2024 from $10 million in Q2 2023, indicating rising costs.
- General and administrative expenses rose to $4.8 million in Q2 2024 from $4.2 million in Q2 2023, primarily due to higher employee-related costs.
- The company's cash, cash equivalents, and investments totaled $28.4 million, which is expected to sustain operations only into the first quarter of 2025.
- The competitive landscape in AML is crowded, posing challenges for Curis Inc (CRIS) in differentiating its offerings.
Q & A Highlights
Q: What is the bar for advancing the PCNSL program forward, and what guideposts are you looking for?
A: We are looking to treat patients who have failed the BTK inhibitor. The goal is to achieve objective responses even after failing on a BTK inhibitor. We aim to demonstrate that adding emavusertib fundamentally changes the efficacy of the regimen, and we anticipate data from at least 15 patients.
Q: Regarding leukemia, what are the different options you can pursue, and how do you plan to approach them?
A: In leukemia, we have options for both monotherapy and combination therapy. The molecule targets IRAK4 and FLT3, making it suitable for both treatment-naïve and experienced patients. We will prioritize which populations to focus on after reporting a more comprehensive data set at ASH.
Q: What are your thoughts on the ideal regulatory path for TakeAim Lymphoma after recent discussions with the FDA?
A: We aim to move expeditiously, given the clear unmet need. We initiated discussions with the FDA ahead of schedule due to compelling data. We are working with both FDA and EMA to find the most expeditious path to make the drug available to patients.
Q: Are you still pursuing the relapsed/refractory path for FLT3 or spliceosome with ema monotherapy?
A: Yes, we have opportunities in both monotherapy and combination therapy for leukemia. We are focusing on NHL due to its advanced state and regulatory discussions. For FLT3 and spliceosome, we will decide on the path after seeing mature data by year-end.
Q: How do you view the opportunity in lymphoma versus AML, and how are you prioritizing them?
A: NHL is a larger market with a clear unmet need, and we are in advanced regulatory discussions. AML is more competitive, but the molecule's design offers unique benefits. We are focusing on NHL due to its advanced data and regulatory progress, but AML remains high on our radar.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
