Financial Data and Key Metrics Changes - Curis reported a net loss of $7.7 million, or $0.49 per share, for Q3 2025, compared to a net loss of $10.1 million, or $1.70 per share, for the same period in 2024, indicating an improvement in financial performance [9] - For the nine months ended September 30, 2025, the net loss was $26.9 million, or $2.19 per share, compared to a net loss of $33.8 million, or $5.77 per share, for the same period in 2024 [9] - Research and development expenses decreased to $6.4 million in Q3 2025 from $9.7 million in Q3 2024, primarily due to lower employee-related costs [9] - General and administrative expenses were $3.7 million in Q3 2025, slightly down from $3.8 million in Q3 2024 [10] - Cash and cash equivalents stood at $9.1 million as of September 30, 2025, with approximately 12.7 million shares of common stock outstanding [10] Business Line Data and Key Metrics Changes - The company is making progress in the take-aim lymphoma study, evaluating emavusertib in combination with ibrutinib for primary CNS lymphoma, with plans for accelerated submissions to the FDA and EMA [3][4] - A proof-of-concept study for CLL patients on BTKI monotherapy is expected to begin enrollment in late Q4 2025 or early Q1 2026, with initial data anticipated at the ASH annual meeting in December 2026 [5] - In the ongoing AML triplet study, MRD conversion to undetectable levels occurred in four of eight evaluable patients, indicating potential effectiveness of the treatment [6][8] Market Data and Key Metrics Changes - The company is focusing on expanding emavusertib studies into additional NHL subtypes, particularly CLL, where there is significant unmet medical need [4][5] - The market opportunity in CLL is viewed as substantial, with expectations of achieving deeper responses and potentially time-limited treatment for patients [20] Company Strategy and Development Direction - Curis aims to improve the current standard of care by adding emavusertib to BTKI regimens, potentially allowing patients to achieve deeper responses and reduce the risk of developing BTKI-resistant mutations [5] - The company is prioritizing the continuation of the PCNSL trial and the launch of the new CLL trial, while also seeking additional capital to support these initiatives [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing studies and the potential to change treatment paradigms in CLL and NHL, highlighting the importance of addressing unmet medical needs [4][20] - The company is preparing for upcoming conferences, including SNO and ASH, where they expect to present significant data and updates [26] Other Important Information - The company is actively engaging with key opinion leaders (KOLs) to explore the potential of emavusertib in various NHL subtypes, indicating strong interest and support from the medical community [4] Q&A Session Summary Question: Insights on the CLL program and FDA discussions - Management confirmed alignment with the FDA on primary endpoints and study design for the CLL study, aiming to address unmet medical needs [12][14] Question: Size of the phase two CLL trial and resource prioritization - The CLL study is anticipated to involve 40 patients, with hopes of achieving a significant increase in complete response rates [17][19] - Resource allocation will focus on continuing the PCNSL trial and launching the CLL trial, with plans to secure additional capital [20] Question: Safety considerations for the CLL study - Management expressed confidence in the safety profile of emavusertib in combination with BTK inhibitors, with no expected additive toxicities [22][24] Question: Expectations for the upcoming SNO meeting - The company will present several posters at the SNO conference, providing updates on the PCNSL study and new data on secondary CNS lymphoma [26]

Core Insights - Curis is focusing on emavusertib, a first-in-class IRAK4 inhibitor, which has shown promising proof-of-concept data in treating various cancers, including lymphoma, leukemia, and solid tumors [3][4]. Company Overview - Curis has a broad pipeline of novel cancer therapies, with a particular emphasis on emavusertib, which has demonstrated significant improvements over standard care in clinical studies [3]. - The leadership team at Curis is highly experienced, with each member having over 20 years of experience in drug development at notable biotech companies [5]. Clinical Data - The proof-of-concept studies for emavusertib include data from 34 patients with primary central nervous system lymphoma (PCNSL) and 21 patients with acute myeloid leukemia (AML), both showing significant efficacy [3]. - The results from the PCNSL study suggest potential effectiveness in other non-Hodgkin lymphoma (NHL) subtypes, including chronic lymphocytic leukemia (CLL) [4]. - The findings in relapsed/refractory AML indicate confidence in the drug's potential application in frontline AML treatment [4].

Core Insights - Curis is focusing on emavusertib, a first-in-class IRAK4 inhibitor, which shows promise in treating various cancers including lymphoma, leukemia, and solid tumors [3][4] - The company has reported proof-of-concept data from studies involving 34 patients with primary central nervous system lymphoma (PCNSL) and 21 patients with acute myeloid leukemia (AML), both showing significant improvements over standard care [3][4] - Curis believes that the positive results from these studies indicate potential efficacy in other subtypes of non-Hodgkin lymphoma (NHL) and frontline AML [4] Company Expertise - Curis boasts a highly experienced leadership team, with each member having over 20 years of experience in drug development at notable biotech firms such as Dicerna, Biogen, BMS, and Merck [5] - The addition of Dr. Ahmed Handy, who has experience in developing BTK inhibitors, is expected to enhance the company's efforts in chronic lymphocytic leukemia (CLL) [5]

Curis (CRIS) Conference Call Summary Company Overview - Curis is at a pivotal stage with a focus on a single drug, an IRAK4 and FLT3 inhibitor, primarily targeting Non-Hodgkin Lymphoma (NHL) and Acute Myeloid Leukemia (AML) [2][3] - The company has a promising pipeline and is conducting studies funded by the NIH in solid tumors [2] Key Drug Insights - The drug is being studied as an add-on therapy to BTK inhibitors, which block the BCR pathway, while Curis's drug targets the TLR pathway, potentially leading to higher response rates and complete remission [3] - Current proof-of-concept data in Primary CNS Lymphoma (PCNSL) shows an overall response rate (ORR) of 63% in a small patient population, compared to a historical ORR of 39% for BTK inhibitors [4][5] Clinical Development and Regulatory Strategy - Curis is pursuing accelerated approval based on a single-arm study, with pivotal status accepted by both the FDA and EMA [6][8] - The company aims to enroll between 45 to 60 patients, targeting an ORR of 20% to 22% to meet regulatory requirements [7][8] - Enrollment is expected to take 12 to 18 months, with plans for a confirmatory randomized study against ibrutinib [9][10] Challenges and Considerations - The ultra-rare nature of PCNSL presents challenges in patient recruitment, with a goal of one patient per site per year across 30 sites globally [9] - There is uncertainty regarding regulatory expectations, particularly concerning overall survival (OS) benefits in single-arm trials [11][12] Expansion into CLL - Curis is initiating a new trial in Chronic Lymphocytic Leukemia (CLL), which represents a larger market opportunity compared to PCNSL [25] - The company aims to combine its drug with BTK inhibitors to enhance efficacy and address unmet needs in CLL treatment [26][27] - The focus will be on patients who are on BTK inhibitors but have not achieved complete remission (CR) [30] Market Dynamics and Competitive Landscape - The CLL market is valued at approximately $11 billion, with BTK inhibitors being the standard of care [25] - Curis's approach aims to provide a time-limited treatment option, addressing the side effects associated with BTK inhibitors and offering a potentially better treatment paradigm [28][44] Clinical Endpoints and Future Directions - The company is considering minimal residual disease (MRD) negativity as a potential endpoint for regulatory approval, reflecting a shift in clinical trial design [32] - Curis plans to present interim data on its CLL trial by mid-year, with expectations of seeing early signs of efficacy [38][39] AML Development - Curis is also looking to combine its drug with azacitidine in AML, aiming for higher response rates and MRD negativity [46][47] - The focus will be on patient tolerability and regimen adjustments to ensure effective long-term treatment [47] Conclusion - Curis is strategically positioned to leverage its unique drug mechanism in both NHL and CLL, with a clear focus on regulatory pathways and market opportunities. The company is actively engaging with regulatory agencies to ensure alignment on clinical endpoints and trial designs, while also addressing the challenges of patient recruitment in rare diseases.

Core Insights - Curis, Inc. has appointed Dr. Ahmed Hamdy as Chief Medical Officer, enhancing its executive team with his extensive industry experience [2][3] - The company is making significant progress towards accelerated approval of its drug emavusertib for relapsed/refractory primary central nervous system lymphoma (PCNSL) in both the U.S. and Europe [2][8] - Curis reported a net loss of $10.6 million for Q1 2025, a slight improvement from a net loss of $11.9 million in Q1 2024, with revenues increasing to $2.4 million from $2.1 million year-over-year [7][18] Management and Strategy - Dr. Hamdy's appointment is expected to contribute positively to Curis's strategic direction, particularly in advancing emavusertib through regulatory processes [2][3] - The company is currently enrolling patients in the TakeAim Lymphoma study to support accelerated approval filings [2][8] Operational Highlights - Curis has successfully completed the first dosing cohort in the Ema-Ven-Aza triplet study for frontline acute myeloid leukemia (AML) and is now commencing the second cohort [5] - The ongoing TakeAim Lymphoma study has received Orphan Drug Designation for emavusertib in both the U.S. and Europe [8] Financial Performance - For Q1 2025, Curis reported revenues of $2.4 million, primarily from royalty revenues related to Erivedge® [7][18] - Research and development expenses decreased to $8.5 million from $9.6 million in Q1 2024, while general and administrative expenses also saw a decline [9][18] - As of March 31, 2025, Curis had cash and cash equivalents totaling $20.3 million, which is expected to support operations into Q4 2025 [11]