Curis(US:CRIS)2023-05-05 01:59Financial Data and Key Metrics Changes - For Q1 2023, the company reported a net loss of $11.6 million or $0.12 per share, compared to a net loss of $16.1 million or $0.18 per share for the same period in 2022 [27] - Revenues for Q1 2023 were $2.3 million, an increase from $2.1 million in Q1 2022 [27] - General and administrative expenses decreased to $4.8 million in Q1 2023 from $5.7 million in Q1 2022, primarily due to lower employee-related costs from headcount reduction [1] - Research and development expenses were $9.1 million in Q1 2023, down from $11.4 million in Q1 2022, attributed to timing of manufacturing costs and lower employee-related costs [28] - As of March 30, 2023, the company had cash, cash equivalents, and investments totaling $71.8 million [3] Business Line Data and Key Metrics Changes - The company is focusing on its lead clinical candidate, emavusertib, which is being evaluated in leukemia and primary central nervous system lymphoma (PCNSL) [22][24] - The enrollment of additional patients for the leukemia study was completed ahead of schedule, indicating strong interest and unmet need in the clinical community [22] Market Data and Key Metrics Changes - The company is targeting the orphan population of patients with high unmet need in PCNSL, which is a new area of focus [24] - The company is optimistic about the potential of emavusertib in combination with ibrutinib for treating PCNSL [24] Company Strategy and Development Direction - The company plans to discuss data with the FDA in Q3 2023, aiming to proceed with a Recommended Phase 2 Dose for emavusertib [23][6] - The strategy includes expanding the executive team with the addition of Dr. Jonathan Zung as Chief Development Officer to strengthen drug development capabilities [25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming discussions with the FDA and the potential for emavusertib to address significant unmet needs in leukemia and PCNSL [23][24] - The management acknowledged the challenges in the regulatory environment but remains committed to advancing their clinical programs [9][8] Other Important Information - The company is currently in a strong cash position, which is expected to support operations into 2025 [3] - The management emphasized the importance of ongoing clinical trials and the potential for emavusertib to overcome resistance in patients previously treated with other therapies [49][54] Q&A Session Summary Question: What is the activity seen in the nine additional patients enrolled in Q1? - The company plans to discuss data with the FDA first before sharing publicly [17] Question: What is the follow-up duration for the 200 mg expansion cohort? - The follow-up time is aligned with the timeline provided, with data expected to be discussed with the FDA in Q3 [48] Question: Will there be follow-up data on the Venetoclax combination? - The company is looking forward to moving forward with combination therapy after lifting the partial hold [59]