Curis(US:CRIS)2022-05-05 22:55Financial Data and Key Metrics Changes - For Q1 2022, Curis reported a net loss of $16 million or $0.18 per share, compared to a net loss of $9.9 million or $0.11 per share in Q1 2021 [26] - Revenues for Q1 2022 were $2.1 million, slightly down from $2.2 million in Q1 2021, with both periods representing royalty revenues from Genentech and Roche's net sales of Erivedge [27] - Operating expenses increased to $17.2 million in Q1 2022 from $11 million in Q1 2021, driven by higher research and development costs [28][29] Business Line Data and Key Metrics Changes - Research and development expenses rose to $11.4 million in Q1 2022 from $6.8 million in Q1 2021, primarily due to increased manufacturing costs and higher personnel-related costs [29] - General and administrative expenses increased to $5.7 million in Q1 2022 from $4.1 million in Q1 2021, attributed to higher personnel costs, stock-based compensation, and consulting services [30] Market Data and Key Metrics Changes - As of March 31, 2022, Curis had cash, cash equivalents, and investments totaling $120.7 million, with approximately 91.6 million shares of common stock outstanding [32] Company Strategy and Development Direction - Curis is focused on developing first-in-class cancer therapies, with a strong emphasis on their lead asset, emavusertib, which is being evaluated in multiple clinical studies [8][22] - The company aims to resolve the partial clinical holds on their studies and is optimistic about the potential for emavusertib to address unmet medical needs in cancer treatment [14][25] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the complexities of clinical development and expressed confidence in their pipeline and strategy despite recent challenges [7][26] - The company is working closely with the FDA to address safety concerns and hopes to provide updated guidance on the timing for discussions regarding a potential rapid registrational path for emavusertib [14][25] Other Important Information - The FDA placed partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma trials due to safety concerns, which the company is actively addressing [12][13] - Curis plans to present updated clinical data at upcoming medical conferences, including ASCO and EHA, to share findings from their studies [11][15] Q&A Session Summary Question: Additional data requested by the FDA - Management is working closely with the FDA to provide additional data regarding a patient who passed away during treatment and to justify the recommended dose of 300 mg BID [34][35] Question: Timeline for submitting data to the FDA - Management has not provided specifics on the timing of data submission to the FDA but will release information as discussions progress [41] Question: Patient eligibility during the clinical hold - Existing patients on study can continue treatment, but new patient enrollment is paused due to the clinical hold [48][49] Question: Impact of clinical hold on R&D expenses - Management indicated that R&D expenses may trend lower in the short term due to the clinical hold, but the long-term impact remains uncertain [52][56] Question: Scope of data readouts in the second half of the year - Management expects to report initial data for emavusertib in combination with ibrutinib and updated data for AML and MDS later in the year, depending on the resolution of the clinical hold [60][61]