Curis FY Conference Summary Company Overview - **Company**: Curis (NasdaqCM:CRIS) - **Focus**: Development of novel cancer treatments, particularly emiflucertib, an IRAK4 inhibitor with applications in lymphoma, leukemia, and solid tumors [2][3] Key Points on Emiflucertib - **Proof of Concept**: - Data from 34 patients with Primary CNS Lymphoma (PCNSL) and 21 patients with Acute Myeloid Leukemia (AML) show significant improvement over standard care [2] - Confidence in efficacy extends to other Non-Hodgkin Lymphoma (NHL) subtypes, including Chronic Lymphocytic Leukemia (CLL) [2][3] - **Mechanism of Action**: - Emiflucertib targets IRAK4, which downregulates NF-kappa B, a key driver in CLL and NHL [5] - Combination therapy with BTK inhibitors enhances treatment efficacy [4][5] - **Market Opportunity**: - BTK inhibitors represent an $11 billion industry, growing at 20% annually, but have limitations such as incomplete responses and side effects [7][8] - Emiflucertib aims to provide a better safety profile and the potential for complete responses [8][14] Clinical Development - **Clinical Trials**: - Designed for accelerated filing, focusing on dose escalation and combination therapy [9][10] - Early data shows promising activity in PCNSL, with plans to expand into other NHL subtypes [10][13] - **Safety Profile**: - Treatment well tolerated with no dose-limiting myelosuppression observed [13][25] - **Regulatory Perspective**: - Increasing receptiveness from FDA and EMA towards Minimal Residual Disease (MRD) as a clinical endpoint [15] AML Insights - **Targeting FLT3 and IRAK4**: - Both are critical in AML, with emiflucertib showing potential to outperform current standards like gilteritinib [17][25] - Data indicates better outcomes in patients who have failed FLT3 inhibitors [25][27] - **Future Studies**: - Plans for a head-to-head registrational study against gilteritinib to establish emiflucertib as a best-in-class treatment for FLT3 AML [26][27] Solid Tumor Potential - **Research Expansion**: - Emiflucertib is being evaluated in five investigator-sponsored trials for solid tumors, with preliminary data expected soon [28] Financial Overview - **Funding**: - As of Q2, Curis has approximately $17 million in funding and a strong intellectual property position extending to 2035 [28] Conclusion - Curis is positioned to leverage its novel IRAK4 inhibitor, emiflucertib, to address significant unmet needs in the oncology market, particularly in NHL and AML, while also exploring opportunities in solid tumors [29][30]