Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP), a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, today reported financial results for the fourth quarter and year-end 2020. The Company also provided clinical and pipeline updates.
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.”
Dr. Cohen continued, “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.”
Clinical Program Updates:
Lenabasum: a novel, oral, selective cannabinoid receptor type 2 (CB2) agonist
|●||Dermatomyositis – The Phase 3 “DETERMINE” study is a double-blind, randomized, placebo-controlled, international study of 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.|
|●||Systemic Lupus Erythematosus – This Phase 2b study is a double-blind, randomized, placebo-controlled, U.S.-based study of safety and efficacy of lenabasum in adult systemic lupus erythematosus patients. The ongoing study is expected to dose 100 subjects at 15 sites. Enrollment is expected to be completed in Q2 2021, and topline results are expected in the second half of 2021. The primary efficacy endpoint is change in maximum daily pain numerical rating score at Week 12, comparing lenabasum groups to placebo. The secondary endpoints include change from baseline in Active Lupus Musculoskeletal Disease Activity (BILAG-2004) and Change from baseline in Lupus Disease Activity (SELENA-SLEDAI Score). The National Institutes of Health is funding and managing this trial.|
|●||Systemic Sclerosis – In 2020, lenabasum did not meet the primary endpoint in the RESOLVE-1 Phase 3 study of lenabasum in systemic sclerosis. Currently no systemic sclerosis patients are being treated with lenabasum. The Company is preparing the data from the RESOLVE-1 study for publication and will decide on the next steps in the development process pending the outcome of the DETERMINE study.|
|●||Cystic Fibrosis – In 2020, lenabasum did not meet the primary endpoint in the Phase 2b study of lenabasum in cystic fibrosis. Corbus is preparing the cystic fibrosis study data for publication, but currently it does not have plans for additional clinical studies.|
|●||The cannabinoid receptor type 1 (CB1) inverse agonist program is in preclinical development for 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 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 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.|
Financial Results for Fourth Quarter and Year-End December 31, 2020:
Revenue from awards and licenses was $700,000 for the three months ended December 31, 2020, compared to $2.6 million in the comparable period in 2019. For the year ended December 31, 2020, revenue from awards and licenses was $3.9 million, compared to $36.1 million in the comparable period in 2019. Revenue for the year ended December 31, 2019 included a $27 million upfront payment received from Kaken Pharmaceutical Co., Ltd. for a license to commercialize and market lenabasum in Japan.
Operating expenses were $21.5 million for the three months ended December 31, 2020, compared to $29.8 million in the comparable period in the prior year. For the year ended December 31, 2020, operating expenses were $126.7 million, compared to $113.2 million in the comparable period in the prior year. Increased expenses for the year were attributable to increased compensation costs, increased clinical trial costs and restructuring costs. Decreased operating expenses quarter over quarter were attributable to the completion of systemic sclerosis and cystic fibrosis in September and October of 2020, respectively. The Company expects expenses to decline in 2021 as a result of the completion in 2020 of clinical trials in systemic sclerosis and cystic fibrosis.
The Company reported a net loss of approximately $8.6 million or a net loss per diluted share of $0.10, for the three months ended December 31, 2020, compared to a net loss of approximately $26.6 million, or a net loss per diluted share of $0.41, for the same period in 2019. For the year ended December 31, 2020, the Company reported a net loss of approximately $111.3 million, or a net loss per diluted share of $1.42, compared to a net loss of approximately $71.5 million, or a net loss per diluted share of $1.12, for the same period in 2019.
Cash and cash equivalents were $85.4 million at December 31, 2020. During the fourth quarter of 2020 the Company raised $20.8 million in net proceeds from the Company’s ATM facility, and in 2021 to date, the Company has raised $58.9 million in net proceeds from the Company’s ATM facility. The $127 million of cash on hand at March 15, 2021 is expected to fund operations into the first quarter of 2024 based on the current planned expenditures.
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