Debra Borchardt
Endocannabinoid drug development company Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) reported financial results for the fourth quarter and year-end 2020. The company said that revenue from awards and licenses was $700,000 for the quarter ending December 31, 2020, versus $2.6 million in the same time period in 2019. Corbus delivered a net loss of approximately $8.6 million or a net loss per diluted share of $0.10, for the quarter versus a net loss of approximately $26.6 million, or a net loss per diluted share of $0.41, for the same period in 2019.
Corbus beat Yahoo Finance analyst estimates which were for a loss of $0.25. The stock was moving higher by over 3% in early trading to sell at $2.42.
For the full year, revenue from awards and licenses was $3.9 million versus $36.1 million in 2019. Revenue for 2019 included a $27 million upfront payment received from Kaken Pharmaceutical Co., Ltd. for a license to commercialize and market lenabasum in Japan. Corbus reported a net loss of approximately $111.3 million for the year or a net loss per diluted share of $1.42, versus a net loss of approximately $71.5 million, or a net loss per diluted share of $1.12, for 2019. The company also said it has $127 million of cash on hand at March 15, 2021, which is expected to fund operations into the first quarter of 2024 based on the current planned expenditures.
Yuval Cohen, Ph.D., Chief Executive Officer said, “We are making progress on our plans to advance development of our internal compounds and expand our pipeline. We look forward to topline results from our DETERMINE Phase 3 study of lenabasum in dermatomyositis in the second quarter. Our CB1 inverse agonist program focusing on metabolic diseases and our CB2 agonist program focusing on oncology continue to progress pre-clinically, and we project to initiate clinical studies next year. We are determined to expand our pipeline and are evaluating a number of potential assets.”
The Phase 3 “DETERMINE” study is an international study of the safety and efficacy of lenabasum in adult dermatomyositis patients. This study enrolled 176 subjects, and all subjects are expected to complete Week 28 of the study this month. The primary efficacy endpoint is Total Improvement Score at Week 28, comparing lenabasum 20 mg twice per day and placebo groups. Topline data are on schedule for Q2 2021. Dermatomyositis is a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation. Dermatomyositis affects approximately 80,000 people in North America, EU, and Japan. There is a significant unmet need for safer and more effective treatments in dermatomyositis because of the limitations of current treatment options.
In October 2020, Corbus had reported that its drug, Lenabasum did not meet its primary efficacy endpoint of reducing the rate of PEx in a Cystic Fibrosis study. Lenabasum is a novel, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2) and resolves inflammation and limits fibrosis in animal and human models of disease.
Pipeline
The company outlined the following updates for its pipeline:
- The cannabinoid receptor type 1 (CB1) inverse agonist program is in preclinical development for the potential treatment of metabolic disorders such as obesity, diabetic nephropathy, diabetic retinopathy, and nonalcoholic steatohepatitis. Several compounds have demonstrated positive data in preclinical models of diet-induced obesity. These data were presented at the New York Academy of Sciences webinar in January 2020. Corbus is moving toward candidate selection and IND-enabling studies and intends to initiate clinical studies in 2022.
- The cannabinoid receptor type 2 (CB2) agonist program is in preclinical development for the potential treatment of cancer, investigating single-agent activity and in combination with other cancer therapies such as checkpoint inhibitors. Several compounds have demonstrated positive data in preclinical models of solid tumors. These data were presented at the New York Academy of Sciences webinar in January 2020. The Company is moving toward candidate selection and IND-enabling studies and intends to initiate clinical studies in 2022.
- Corbus is actively engaging with potential partners to expand its pipeline through the acquisition of external assets. The Company is focusing on biology beyond the endocannabinoid system and new indications that will still leverage its expertise and capabilities within immunology.
Dr. Cohen added, “We are fortunate to be in a strong financial position with approximately $127M of cash on hand, which is expected to fund the Company into the first quarter of 2024.”
