Financial Data and Key Metrics Changes - Curis reported a net loss of $8.6 million or $0.68 per share for Q2 2025, compared to a net loss of $11.8 million or $2.03 per share for the same period in 2024, indicating an improvement in financial performance [11] - Research and development expenses decreased to $7.5 million in Q2 2025 from $10.3 million in Q2 2024, primarily due to lower employee-related costs and clinical expenses [11] - General and administrative expenses also decreased to $3.5 million in Q2 2025 from $4.8 million in Q2 2024, reflecting reduced employee-related and legal costs [12] Business Line Data and Key Metrics Changes - The company is focused on the "take aim lymphoma" study evaluating emigosertib in combination with ibrutinib for patients with primary CNS lymphoma (PCNSL), with plans to enroll 30 to 40 additional patients over the next 12 to 18 months [5][6] - In the AML segment, emivocertib showed a 38% composite complete response (CR) rate in relapsed/refractory AML patients with FLT3 mutations, compared to 21% for gilteritinib, indicating a competitive edge [8][9] Market Data and Key Metrics Changes - The company is exploring emivacertib's potential in high-risk myelodysplastic syndromes (MDS) following the failure of the Varonis study, which has generated interest in combining azacitidine with emivacertib [10] - The competitive landscape in CLL is evolving with the introduction of BTK degraders and next-generation BCL2 inhibitors, but the company believes there is still room for its combination therapy [18][20] Company Strategy and Development Direction - Curis aims to improve the standard of care for CLL and NHL patients by adding emivacertib to BTK inhibitors, potentially allowing patients to achieve deeper responses and reduce the risk of resistance [7] - The company is also planning a registrational study comparing emivacertib to gilteritinib in the relapsed/refractory AML setting, indicating a strategic focus on expanding its treatment options [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing discussions with the FDA and EMA regarding accelerated submissions for the lymphoma study, despite the current uncertain regulatory environment [39] - The company believes its lead indication in NHL, particularly in PCNSL where there are no approved drugs, positions it favorably for future growth [39] Other Important Information - Curis completed a registered direct offering and private placement in July 2025, raising approximately $6 million, which, along with existing cash, is expected to fund operations into 2026 [12] - The company has over 30 clinical sites open for patient enrollment in the lymphoma study, with expectations of enrolling one patient per site per year due to the ultra-rare nature of the indication [24] Q&A Session Summary Question: What do you think the bar would be for the BTK combination study in CLL? - Management believes that adding emivacertib to a commercially available BTK inhibitor can lead to minimal residual disease (MRD) negativity or complete remissions, addressing an unmet medical need in CLL [16][17] Question: Can you provide any color on enrollment progression for the lymphoma study? - Enrollment is steady but challenging due to the ultra-rare population, with expectations of one patient per site per year [24][30] Question: How do you plan to prioritize development between PCNSL and CLL? - The company is actively discussing how to allocate resources efficiently, given the compelling data and multiple potential studies [48] Question: What is the status of discussions with the FDA regarding accelerated approval? - Management confirmed that discussions with the FDA remain positive and aligned with key activities [39] Question: Are there any updates on the investigator-sponsored solid tumor studies? - There are no current updates, but the company is hopeful for data from at least one study this year [51]

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024, indicating an improvement in loss per share [12] - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, primarily due to lower employee-related costs [12] - General and administrative expenses also decreased to $4 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related costs and professional fees [12] - Cash and cash equivalents totaled $20.3 million as of March 31, 2025, with expectations to fund operations into Q4 2025 [13] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is evaluating emavucertib in combination with ibrutinib in patients with relapsed/refractory primary CNS lymphoma (PCNSL), with 27 patients treated as of the latest data cutoff [8] - Among 20 BTKi experienced patients, 9 showed a reduction in tumor burden, including 6 objective responses, while 5 out of 7 BTKi naive patients also demonstrated a reduction [8] - In the AML segment, a 38% composite complete response (CR) rate was reported in a study involving patients with FLT3 mutations, showcasing the potential of emavucertib [10] Market Data and Key Metrics Changes - The company is focusing on expanding the use of emavucertib beyond primary CNS lymphoma into additional indications such as NHL, AML, and solid tumors [5] - The enrollment for the lymphoma study is ongoing, with 37 sites currently open across major centers in the U.S., Europe, and Israel [20] Company Strategy and Development Direction - Curis is prioritizing the PCNSL study while simultaneously advancing its AML studies, with a focus on safety and tolerability in frontline AML [18] - The company aims to enroll 30 to 40 additional patients for NDA submission in the lymphoma study, targeting 6 to 8 responses in that dataset [9] - The addition of Dr. Ahmed Hamdy to the executive team is expected to enhance the company's strategic direction in both lymphoma and AML [4][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with the FDA, indicating no concerns about changes affecting their agreement despite industry turmoil [28] - The company is optimistic about the potential of emavucertib, particularly in combination therapies, and is focused on maximizing its utility across various indications [37] Other Important Information - Curis completed a registered direct financing and private placement in March 2025, raising approximately $8.8 million [13] - The company plans to provide additional updates on the Take Aim Lymphoma study at the upcoming ASH conference later this year [9] Q&A Session Summary Question: Positioning of lymphoma versus AML - Management confirmed that resources are primarily dedicated to the PCNSL study while also advancing AML studies, with a focus on safety and initial patient enrollment [18][22] Question: Enrollment and FDA discussions - Management stated that they are on track with enrollment and have no concerns regarding their agreement with the FDA, appreciating the timing of their collaboration [28] Question: Mutations affecting responses and EMA development steps - Management indicated it is too early to discuss specific mutations impacting responses, emphasizing the mechanism of action instead [34] - Future plans for AML development will be discussed after completing the ongoing triplet study [36]

Financial Data and Key Metrics Changes - Curis reported a net loss of $10.6 million or $1.25 per share for Q1 2025, compared to a net loss of $11.9 million or $2.05 per share for the same period in 2024, indicating an improvement in loss per share [12] - Research and development expenses decreased to $8.5 million in Q1 2025 from $9.6 million in Q1 2024, primarily due to lower employee-related costs [12] - General and administrative expenses also decreased to $4 million in Q1 2025 from $4.9 million in Q1 2024, attributed to lower employee-related costs and professional fees [12] - Cash and cash equivalents totaled $20.3 million as of March 31, 2025, with the company expecting this to support operations into Q4 2025 [13] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is progressing, evaluating emavucertib in combination with ibrutinib in patients with relapsed/refractory primary CNS lymphoma [7] - As of January 2, 2025, 27 patients have been treated with the emavucertib and ibrutinib combination, showing promising results in tumor burden reduction [8] - In AML, a 38% composite complete response rate was observed in a study of 21 patients with FLT3 mutations treated with emavucertib, which is significantly higher than the 21% rate for gilteritinib [10] Market Data and Key Metrics Changes - The company is focusing on expanding the use of emavucertib beyond primary CNS lymphoma into additional indications such as NHL, AML, and solid tumors [5] - The enrollment for the lymphoma study is ongoing, with 37 sites currently open across the U.S., Europe, and Israel [20] Company Strategy and Development Direction - Curis is prioritizing the PCNSL study while also advancing its AML studies, with a focus on safety and tolerability in the frontline setting [18] - The company aims to enroll 30 to 40 additional patients for NDA submission in the lymphoma study, targeting six to eight responses in that dataset [9] - The addition of Dr. Ahmad Hamdi to the executive team is expected to enhance the company's strategic direction in expanding treatment options [4] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the collaboration with the FDA, indicating no concerns about changes affecting their agreement [28] - The company is optimistic about the potential of emavucertib in combination therapies and is focused on maximizing its utility across various indications [36] Other Important Information - Curis completed a registered direct financing and private placement in March 2025, raising approximately $8.8 million [13] - The company plans to provide additional updates on the Take Aim Lymphoma study at the ASH conference later this year [9] Q&A Session Summary Question: Positioning of lymphoma versus AML - Management is advancing both lymphoma and AML studies simultaneously, with more resources allocated to the PCNSL study due to its advanced stage [18] Question: Enrollment in lymphoma study and FDA conversations - Enrollment is on track with 37 sites open, and management is confident in their collaboration with the FDA [25][28] Question: Mutations affecting responses and AML development steps - It is too early to discuss specific mutations affecting responses; the focus is on the mechanism of action [33] - Future plans for AML development will be discussed after completing the ongoing triplet study [35]