Corbus Pharmaceuticals(CRBP) - 2019 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Corbus Pharmaceuticals ended Q3 2019 with approximately $55 million in cash, which is expected to be sufficient to support operations through key data readouts and into Q3 2020 [18] Business Line Data and Key Metrics Changes - The RESOLVE-1 global Phase 3 study of lenabasum in systemic sclerosis is fully enrolled with 365 patients dosed, with top-line data expected next summer [7] - The DETERMINE global Phase 3 study of lenabasum in dermatomyositis is actively enrolling subjects, with expectations to complete enrollment in 2020 and top-line results in 2021 [8] - The 415 patient Phase 2b study in cystic fibrosis is ongoing, with top-line data expected in summer 2020 [10] Market Data and Key Metrics Changes - Market research indicates a strong need for new anti-inflammatory treatments in cystic fibrosis, particularly for patients with established lung disease who continue to experience exacerbations [16] Company Strategy and Development Direction - The company is focused on preparing for the commercial launch of lenabasum, building a commercial leadership team, and establishing market insights [14] - Corbus aims to explore additional partnerships abroad, particularly in Asia, to increase global reach [18] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding upcoming data from Phase 3 studies and the potential for lenabasum to reshape treatment paradigms for inflammatory and fibrotic diseases [6][18] - The company is preparing for a successful launch and is actively engaging with patients and physicians to understand the unmet needs in systemic sclerosis and cystic fibrosis [15][16] Other Important Information - The second drug in the pipeline, CRB-4001, is targeting NASH with fibrosis, with a Phase 1 safety study scheduled for readout in 2020 [11] - The company highlighted eight promising compounds at their R&D Day, which are progressing through candidate selection [11] Q&A Session Summary Question: Key learnings from systemic sclerosis patients on treatment and expectations for ACR data - Management expects to see a favorable long-term safety profile and durable efficacy data in the upcoming ACR presentation [23] Question: Impact of recent changes in standard of care on the Phase 2b study in cystic fibrosis - Management believes lenabasum will offer treatment benefits on top of existing standard care treatments, and they are prepared for statistical sensitivity analysis [25] Question: Updates on formulation work for CRB-4001 and timelines for PET data - Management is optimistic about the formulation for CRB-4001 and expects to have readouts from the Phase 1 study in 2020, but timelines for PET data remain uncertain [30] Question: Focus areas for ACR updates and competitive landscape - Management highlighted the importance of safety and efficacy data in their presentations at ACR, and they expect to be the first to seek approval for systemic sclerosis treatments [36] Question: Progress on preclinical CB programs and potential partnerships - Management indicated that they are making progress with their internal compounds and anticipate moving forward with candidate selection in the coming months [38]