Curis(CRIS) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Curis reported a net loss of $9.6 million or$1.25 per share for Q4 2024, compared to a net loss of $117 million or$2.03 per share for the same period in 2023 [19] - For the full year 2024, the net loss was $43.4 million or$6.88 per share, compared to a net loss of $47.4 million or$8.96 per share in 2023 [19] - Research and development expenses were $9 million for Q4 2024, down from$10 million in Q4 2023, primarily due to lower clinical and research costs [19][20] - General and administrative expenses decreased to $3.4 million in Q4 2024 from$4.9 million in Q4 2023, attributed to lower legal and consulting costs [20][21] Business Line Data and Key Metrics Changes - In the NHL segment, the TakeAim Lymphoma study is evaluating emavusertib in combination with ibrutinib, with positive feedback from EMA and FDA regarding potential accelerated approval pathways [6][12] - The study has 30 clinical sites open for enrollment, aiming to complete enrollment in the next 12 to 18 months [8][12] - In the AML segment, emavusertib showed a 38% composite CR rate in a study involving patients with FLT3 mutations, indicating strong efficacy compared to existing treatments [14][15] Market Data and Key Metrics Changes - The company has received Orphan Drug Designation for emavusertib in primary CNS lymphoma in both the U.S. and Europe, enhancing its market position [12] - The discussions with regulatory agencies indicate a favorable environment for potential approvals, as there are currently no approved treatments for primary CNS lymphoma [43] Company Strategy and Development Direction - The company is focused on accelerating the development timeline for emavusertib, with plans to enroll additional patients to support filings for accelerated approval [8][12] - There is an ongoing strategy to explore partnerships with major players in the NHL and AML spaces, indicating a proactive approach to enhance its market presence [28] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the clinical data and the clarity received from regulatory agencies, which supports the company's development plans [12][42] - The company anticipates maintaining a cash runway into Q4 2025, with a quarterly burn rate of approximately $10 million [26][22] Other Important Information - The company completed a registered direct offering and private placement with net proceeds of approximately$10.8 million, extending its financial runway [21] - The company is currently conducting a Phase 1 study of emavusertib in combination with venetoclax and azacitidine for frontline AML, with ongoing enrollment [16][52] Q&A Session Summary Question: Can you talk about cash runway and expenses going forward? - Management confirmed a quarterly burn rate of about $10 million, extending the cash runway to Q4 2025 due to recent offerings [26] Question: Any potential inbound interest from partners? - Management indicated ongoing discussions with potential partners, given the promising data in NHL and AML [28] Question: How many patients have been dosed with emavusertib? - A total of 13 patients have been dosed at 100 mg BID in the study [35] Question: What does the EMA expect in terms of response rates? - Management noted that both agencies are supportive and expect compelling data, with a response rate above 25% being favorable [43] Question: How should we think about TakeAim Leukemia? - Management emphasized caution regarding data expectations in leukemia but highlighted ongoing studies and interest in monotherapy extensions [50][55]