Corbus Pharmaceuticals(CRBP) - 2020 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended the quarter with $46.6 million in cash and cash equivalents, maintaining guidance to fund operations into the fourth quarter of 2020 with remaining milestone payments of $7.5 million from the Cystic Fibrosis Foundation Award [33] Business Line Data and Key Metrics Changes - The RESOLVE 1 Phase 3 study in systemic sclerosis is on schedule, with topline data expected in summer 2020, followed by data from the Phase 2b lenabasum study in cystic fibrosis [8][9] - Enrollment in the Phase 3 DETERMINE study in dermatomyositis is about 80%, with completion anticipated in the third quarter of 2020 [16] Market Data and Key Metrics Changes - A survey conducted with 100 U.S.-based rheumatologists revealed that nearly half of their systemic sclerosis patients suffer from the diffuse cutaneous form of the disease, highlighting the unmet need [22][24] - Approximately 50% of respondents were familiar with the cannabinoid receptor Type 2 as a potential treatment mechanism, and about 30% were aware of lenabasum as a future treatment [25] Company Strategy and Development Direction - The company is focused on preparing for NDA submission and commercialization following FDA approval, with multiple data readouts and catalysts anticipated in the coming months [9][34] - A disease education campaign is underway to provide rheumatologists with relevant scientific information on systemic sclerosis, emphasizing the unmet need and potential treatments [28][29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the second half of the year, citing multiple data readouts as the most significant period since the company's founding [34] - The company does not anticipate significant delays in data collection due to COVID-19, with remote data monitoring procedures in place [10][41] Other Important Information - The Phase 1 study of CRB-4001 is on schedule to start in the third quarter of 2020, with additional work being done to expand the pipeline [18][20] - The company has implemented new remote working procedures and data monitoring to ensure the safety and integrity of ongoing clinical trials during the pandemic [11][12] Q&A Session Summary Question: Data collection in the RESOLVE 1 study - Management confirmed that 99% of patients have completed dosing, with data collection ongoing for the 28-day safety follow-up [38][41] Question: Relationship between mRSS and CRISS score - Management stated that the minimal important difference for mRSS will be determined at the end of the study, with no speculation on current values [47][50] Question: Enrollment in the open-label extension - Management clarified that eligibility for the open-label extension includes patients who completed dosing in the double-blind study, with over 300 patients currently enrolled [69] Question: Timing of data results - Management indicated that topline data for cystic fibrosis will be released approximately a month after the systemic sclerosis data [71] Question: Website information collection - The website is directed at rheumatologists, not patients, and aims to build a database of interested physicians while providing disease education [55]