Curis(US:CRIS)2020-08-05 00:57Financial Data and Key Metrics Changes - Curis reported a net loss of $6.7 million or $0.17 per share for Q2 2020, compared to a net loss of $7.2 million or $0.22 per share for the same period in 2019 [25] - Revenues for Q2 2020 were $2.4 million, an increase from $2.1 million in Q2 2019, primarily from royalty revenues related to Erivedge [25] - Operating expenses decreased to $7.8 million in Q2 2020 from $8.2 million in Q2 2019, with R&D expenses at $5.3 million, down from $5.6 million [26] Business Line Data and Key Metrics Changes - The company advanced its IRAK4 program, CA-4948, in ongoing studies for non-Hodgkin's lymphoma and initiated a second study for acute myeloid leukemia [6][7] - The enrollment pace for the Phase I study of CA-4948 slowed due to COVID-19, but sites have reopened and are actively enrolling patients [10] - The company plans to initiate a combination study of CA-4948 with ibrutinib, leveraging preclinical data showing significant anticancer benefits [11][12] Market Data and Key Metrics Changes - The company received FDA clearance for its investigational new drug application for CI-8993, a monoclonal anti-VISTA antibody, marking a significant milestone in its pipeline [7][24] - The competitive landscape in oncology is evolving, with Curis focusing on the unique targeting of IRAK4-L, a key driver of disease in AML and MDS [46][47] Company Strategy and Development Direction - Curis aims to develop targeted cancer therapies addressing unmet patient needs, with a focus on advancing its clinical pipeline and achieving data catalysts in the near future [5][8] - The company is strategically pursuing both monotherapy and combination therapy approaches in its clinical studies, particularly in indications where ibrutinib is used [39][56] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the impact of COVID-19 on clinical trial enrollment but expressed confidence in resuming progress and achieving key milestones by year-end [30] - The focus for the remainder of the year is on safety data for CI-8993, with efficacy data expected in the following year [62][66] Other Important Information - As of June 30, 2020, Curis had cash, cash equivalents, and investments totaling $23.6 million, expected to support operations into the first half of 2021 [28] - The company anticipates maintaining a cash burn of $7 million to $8 million per quarter for the remainder of the year [69] Q&A Session Summary Question: Impact of COVID on CA-4948 data release - Management confirmed that COVID-19 affected enrollment but expressed confidence in finalizing Phase II dosing by year-end [30] Question: Dose level for CA-4948 and ibrutinib combination - The company plans to start the combination study with a therapeutic dose of 200 mg, with potential for dose escalation based on patient response [32] Question: Rate-limiting factors for anti-VISTA program - Management indicated no significant rate-limiting factors, with productive discussions with the FDA facilitating rapid progress [33] Question: Patient demographics in NHL studies - Enrollment includes a diverse mix of relapsed/refractory patients, averaging 3.5 lines of prior therapy [36] Question: Competitive landscape for AML and MDS - Management acknowledged evolving treatment algorithms and emphasized the unique targeting of IRAK4 as a key component in treating these diseases [42][46] Question: Future data release venues - The company aims to release data at medical conferences, with plans for top-line information followed by detailed presentations [50] Question: Focus on DLBCL in future studies - Management plans to pursue both DLBCL and other indications where ibrutinib is used, based on preclinical data supporting synergy [56][58] Question: Safety focus for CI-8993 - The emphasis for this year is on safety management, particularly regarding cytokine release syndrome [62][66] Question: Operating expenses guidance - Management expects operating expenses to remain consistent in the second half of the year, with a cash burn estimate of $7 million to $8 million per quarter [69]