Corbus Pharmaceuticals(US:CRBP)2020-11-10 18:53Financial Data and Key Metrics Changes - The company underwent a significant restructuring to reduce costs and extend its cash runway to $82 million, projected to last until mid-2022 [34] - The company reported disappointing top-line data from its Phase 3 study in systemic sclerosis and Phase 2b study in cystic fibrosis, with lenabasum not meeting its primary endpoints [8][16] Business Line Data and Key Metrics Changes - The Phase 3 study of lenabasum in systemic sclerosis did not meet its primary endpoint, but post-hoc analyses suggested potential clinical activity in patients on established immunosuppressants [16][20] - In the Phase 2b study for cystic fibrosis, lenabasum treatment was associated with a maximum reduction of pulmonary exacerbations by up to 62% in specific patient subsets [24] Market Data and Key Metrics Changes - The dermatomyositis market presents a significant opportunity with approximately 30,000 patients in the U.S. and a clear unmet need [11] - The company plans to shorten the duration of the Phase 3 DETERMINE study from one year to 28 weeks to align with competitive studies and accelerate topline data readouts [12][28] Company Strategy and Development Direction - The company aims to rebuild shareholder value through three concepts: demonstrating lenabasum's clinical activity, focusing on dermatomyositis as a value driver, and leveraging its pipeline beyond lenabasum [9][11][13] - The company is evaluating options for expanding its pipeline with external assets that complement its current capabilities [14] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges faced in recent trials but remains optimistic about the potential of lenabasum in specific indications [8][10] - The company is committed to collaborating with experts in systemic sclerosis and cystic fibrosis to explore future study designs and regulatory pathways [36][60] Other Important Information - The company has a promising preclinical program involving a novel family of CB2 agonists that may inhibit tumor cell growth [32] - The Chief Operating Officer has resigned, which may impact the company's leadership dynamics [35] Q&A Session Summary Question: Rationale behind shortening the dermatomyositis study - Management noted that the study duration was adjusted based on competitive landscape and preliminary data indicating that most improvements occur within the first six months [40][42] Question: Limitations observed with CRB-4001 - Management identified formulation challenges and concerns regarding blood-brain barrier penetration as key issues with CRB-4001, leading to a shift in focus to more promising compounds [46][48] Question: Regulatory path for systemic sclerosis trial - Management clarified that the recent Phase 3 study is not adequate for regulatory approval, and further studies will be necessary to support a new application [50][51] Question: Feedback from the cystic fibrosis community - Management indicated ongoing discussions with the cystic fibrosis community but emphasized that the failure to meet the primary endpoint limits the current trial's utility for approval [52] Question: Future development candidates for CB1 inverse agonists - Management plans to prioritize one promising compound for clinical development while keeping options open for others based on preclinical data [61]