PresentationJames DentzerPresident, CEO, Secretary, Treasurer & Director Good afternoon. I'm Jim Dentzer, the CEO of Curis. Thank you for taking time today to learn more about us. Over the next 25 minutes, I'll walk through a summary of our progress to date. Before I begin, I'd like to remind everyone that during the presentation, we'll be making forward-looking statements, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and actual re ...

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]