Financial Data and Key Metrics Changes - Curis reported a net income of $19.4 million or $1.23 per share for Q4 2025, compared to a net loss of $9.6 million or $1.25 per share for the same period in 2024, primarily due to a $27.2 million one-time non-cash gain from the sale of Erivedge [10] - For the year ended December 31, 2025, the net loss was $7.6 million or $0.58 per share, a significant improvement from a net loss of $43.4 million or $6.88 per share in 2024 [10] - Research and development expenses decreased to $5.8 million in Q4 2025 from $9 million in Q4 2024, and for the year, they were $28.3 million compared to $38.6 million in 2024 [11] - General and administrative expenses also decreased to $2.9 million in Q4 2025 from $3.4 million in Q4 2024, totaling $14 million for the year compared to $16.8 million in 2024 [11] Business Line Data and Key Metrics Changes - The company is making progress in its Take Aim Lymphoma study for primary CNS lymphoma, with expectations for accelerated submissions to the FDA and EMA [4] - Curis is expanding studies of emavusertib into additional NHL subtypes, particularly focusing on its potential to change the treatment paradigm for CLL patients [5][6] Market Data and Key Metrics Changes - The company is actively enrolling patients in its registrational study for PCNSL, with expectations to complete enrollment within 12-18 months [23] - Initial data from the ongoing AML triplet study showed that five of eight evaluable patients achieved MRD conversion, indicating potential for deeper responses [8][9] Company Strategy and Development Direction - Curis is prioritizing its resources towards NHL studies, particularly PCNSL, while also initiating a proof of concept study in CLL [15] - The company aims to improve treatment outcomes by combining emavusertib with existing therapies to achieve deeper responses and potentially complete remission for patients [6][42] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential for significant advancements in 2026, particularly in the registrational study for PCNSL and the proof of concept study in CLL [9] - The company anticipates no meaningful revenue in 2026 due to the cessation of cash flows from Erivedge, but believes it has sufficient cash to fund operations into the second half of 2027 [12][29] Other Important Information - Curis has received initial gross proceeds of $20.2 million from financing in January 2026, with expectations for additional proceeds from warrant exercises [12] Q&A Session Summary Question: How is the company prioritizing trial progress between pivotal PCNSL versus CLL and AML? - Management indicated that resources are being prioritized towards NHL, particularly PCNSL, while CLL is in the early stages of study [14][15] Question: Can you provide updates on enrollment for PCNSL? - Management stated that enrollment is on track, with expectations for full enrollment within 12-18 months [23] Question: Should revenue modeling for 2026 reflect no meaningful revenue? - Management confirmed that there will be no meaningful revenue in 2026, as cash flows from Erivedge have ended [29] Question: What kind of data should be expected at ASH 2026 regarding CLL? - Management indicated that they hope to present meaningful data at ASH, focusing on the potential for deeper responses in patients [39][40]

Financial Data and Key Metrics Changes - Curis reported a net income of $19.4 million or $1.23 per share for Q4 2025, compared to a net loss of $9.6 million or $1.25 per share for Q4 2024, primarily due to a $27.2 million one-time non-cash gain from the sale of Erivedge [10] - For the year ended December 31, 2025, Curis reported a net loss of $7.6 million or $0.58 per share, an improvement from a net loss of $43.4 million or $6.88 per share for the same period in 2024 [10] - Research and development expenses decreased to $5.8 million in Q4 2025 from $9 million in Q4 2024, and for the year, they were $28.3 million compared to $38.6 million in 2024 [11] - General and administrative expenses also decreased to $2.9 million in Q4 2025 from $3.4 million in Q4 2024, totaling $14 million for the year compared to $16.8 million in 2024 [11] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study is progressing well, focusing on primary CNS lymphoma, with expectations for accelerated submissions in the U.S. and Europe [4][9] - Curis is exploring the potential of emavusertib to change treatment paradigms in CLL, aiming to improve upon the current standard of care with BTK inhibitors [5][6] Market Data and Key Metrics Changes - Enrollment in the Take Aim Lymphoma study is on track, with expectations for full enrollment within 12-18 months, potentially leading to data availability in 2027 [23] - The company is prioritizing NHL studies over AML, with a focus on registrational approval for PCNSL [15][16] Company Strategy and Development Direction - Curis aims to change the treatment paradigm for CLL by combining emavusertib with BTK inhibitors, targeting deeper responses and potential complete remission [6][7] - The company is actively engaging with key opinion leaders to expand studies into additional NHL subtypes, indicating a strategic focus on broadening its clinical research [5] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential for significant advancements in 2026, particularly in the registrational study for PCNSL and the proof of concept study for CLL [9] - The management acknowledged the challenges in patient enrollment for PCNSL but remains confident in the study's trajectory [23] Other Important Information - Curis' cash and cash equivalents as of December 31, 2025, along with expected proceeds from financing, should support operations into the second half of 2027 [12] Q&A Session Summary Question: How is Curis prioritizing trial progress between pivotal PCNSL versus CLL and AML? - Management indicated that resources are being prioritized towards NHL, particularly PCNSL, while CLL is also a focus but at a smaller scale currently [14][15] Question: Can you provide updates on enrollment for PCNSL? - Management confirmed that enrollment is on track, with expectations for full enrollment within 12-18 months [23] Question: Should revenue modeling for 2026 reflect no meaningful revenue? - Management confirmed that there will be no meaningful revenue for 2026, as revenue effectively ended in November 2025 [29] Question: What kind of data should be expected at ASH 2026 for CLL? - Management stated that they hope to present meaningful data at ASH, focusing on the execution of the study and patient enrollment [38][40]

Financial Data and Key Metrics Changes - Curis reported a net income of $19.4 million or $1.23 per share for Q4 2025, compared to a net loss of $9.6 million or $1.25 per share for Q4 2024, primarily due to a $27.2 million one-time non-cash gain from the sale of Erivedge [10] - For the year ended December 31, 2025, the net loss was $7.6 million or $0.58 per share, a significant improvement from a net loss of $43.4 million or $6.88 per share in 2024 [10] - Research and development expenses decreased to $5.8 million in Q4 2025 from $9 million in Q4 2024, and for the year, they were $28.3 million compared to $38.6 million in 2024 [11] - General and administrative expenses also decreased to $2.9 million in Q4 2025 from $3.4 million in Q4 2024, totaling $14 million for the year compared to $16.8 million in 2024 [11] Business Line Data and Key Metrics Changes - The Take Aim Lymphoma study in primary CNS lymphoma is progressing well, with expectations for accelerated submissions in the U.S. and Europe [4] - Initial data from the ongoing AML triplet study showed that 5 of 8 evaluable patients achieved MRD conversion, indicating potential effectiveness of the treatment combination [8][9] Market Data and Key Metrics Changes - The company is focusing on expanding emavusertib studies into additional NHL subtypes, particularly CLL, where current treatments have limitations [5][6] - The company is prioritizing NHL studies over AML due to resource allocation and the potential for registrational approval in PCNSL [14][15] Company Strategy and Development Direction - Curis aims to improve the treatment paradigm for CLL by combining emavusertib with BTKI regimens, targeting deeper responses and potential complete remission [6][39] - The company is actively engaging with clinical sites in the U.S. and Europe to advance its studies and expects to present initial data at the ASH annual meeting in December [7][9] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical trials and the potential for significant advancements in treatment options for patients with CLL and NHL [4][9] - The company anticipates no meaningful revenue in 2026 due to the cessation of cash flows from Erivedge, but is confident in its financial position to support operations into the second half of 2027 [12][27] Other Important Information - Curis has secured initial gross proceeds of $20.2 million from financing, which will support its operations and clinical trials [12] Q&A Session Summary Question: How is the company prioritizing trial progress between pivotal PCNSL versus CLL and AML? - Management indicated that resources are being prioritized towards NHL, particularly PCNSL, while CLL is in the early stages of study [14][15] Question: Can you provide updates on PCNSL enrollment? - Management confirmed that enrollment is on track, with expectations for full enrollment within 12-18 months [22] Question: Should revenue modeling reflect no meaningful revenue for 2026? - Management confirmed that there will be no meaningful revenue, as cash flows from Erivedge have ended [27][28] Question: What data should be expected at ASH 2026 for CLL? - Management stated that they hope to present meaningful data regarding the treatment's effectiveness, focusing on deepening patient responses [35][36]

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]