Curis(US:CRIS)2025-11-06 22:30Financial 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]