Corbus Pharmaceutical Archives - Green Market Report

Debra BorchardtMarch 15, 2021
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6min9460

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.”


Debra BorchardtOctober 23, 2020
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4min14811

Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) reported that its drug, Lenabasum did not meet its primary efficacy endpoint of reducing the rate of PEx. 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. CB2 is preferentially expressed on activated immune cells and on fibroblasts, muscle cells, and endothelial cells.

“While I am disappointed that the study did not achieve its primary endpoint, I am encouraged by findings of potential reduction in exacerbation rates in subjects with similar lung function and treatment with CFTR-modulators,” said James Chmiel, M.D., MPH, Principal Investigator of CF-002. “I look forward to further analyses of the data, because they may confirm the initial clinical rationale to continue development of lenabasum for treatment of pulmonary exacerbations in people with CF. This was the first interventional study in CF to select for patients who have high rates of pulmonary exacerbations and one of the largest CF studies to date. The negative impact of recurrent pulmonary exacerbations on the health and quality of life of people with CF cannot be overstated, nor can the need to find non-immunosuppressive treatments to control the lung inflammation that causes these events.”

The company announced the presentation of the preliminary data from its 28-week Phase 2b study of lenabasum in patients with cystic fibrosis (CF) at the North American Cystic Fibrosis Conference (NACFC) held online, Oct 7-23, 2020. The data are being presented in poster number 817 titled: “CB2 Agonist, Lenabasum, for the Treatment of Pulmonary Exacerbations in Cystic Fibrosis.” These data can be found at the following link: NACFC Poster #817

Study design

CF-002 was a multinational Phase 2b study evaluating the efficacy and safety of lenabasum in CF. This was a double-blind, randomized, placebo-controlled study, with dosing of lenabasum at 5 mg twice per day, lenabasum 20 mg twice per day or placebo twice per day for 28 weeks, with 4 weeks safety follow-up off active treatment. The primary efficacy endpoint was the event rate of new PEx per subject per 28 weeks, when the primary definition of new PEx was physician diagnosis of PEx, prescription of new antibiotics for that PEx starting more than 28 days after completion of the last antibiotic course for any previous PEx, with 4 out of 12 Fuch’s criteria present in the subject. The Phase 2b CF study was funded in part by a Therapeutic Development Award for up to $25 Million from the Cystic Fibrosis Foundation.

Company Reorganization

A few weeks ago, Corbus said it would reallocate resources towards its lenabasum clinical development program in dermatomyositis and systemic lupus erythematosus and its pipeline of other novel ECS-targeting drug candidates. The pipeline includes cannabinoid receptor type 1 (CB1) inverse agonists, follow-on cannabinoid receptor type 2 (CB2) agonists, as well as other programs with their own unique mechanism of action in the ECS field. The Company is allocating resources and implementing cost reductions designed with the objective of extending its cash runway to mid-2022. Corbus recorded cash and cash equivalents of approximately $83 million at September 30, 2020.


William SumnerJanuary 31, 2018
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3min19902

Research Driven Investing (RDI) has initiated coverage on Corbus Pharmaceuticals Holdings, Inc. (CRBP) with a Neutral rating. Corbus Pharmaceuticals late-stage stage clinical pharmaceutical company that is focused on the development and commercialization of unique medicines aimed at treating inflammatory and fibrotic diseases.

Based in Norwood, Massachusetts, the company’s lead product is JBT-101, an oral endocannabinoid-mimetic drug. JBT-101 is currently in Phase 2 trials for the treatment of systemic sclerosis, cystic fibrosis, diffuse cutaneous, skin-predominant dermatomyositis, and systemic lupus erythematosus diseases.

The company’s stock took a slight tumble on Tuesday, falling 11.89% to close out the day at $8.15. The stock’s 50-day moving average is $7.83, which is slightly greater than its 200-day moving average of $7.06. The company’s stock has recorded a trading volume of 4,306,752 shares, well above its three month average of 789,806 shares. In the last year, Corbus Pharmaceuticals shares have traded between $5.30-$10.50. Overall, the company stock has gained approximately 53.77% in value from its 52 week low. In the past month, the the company’s stock has risen 14.79% in value.

Research Driven Investing is a New York based firm which provides equity reports for investors with short term and long-term growth opportunities. Specializing in Large-Cap Equity Reports, RDI provides retail investors with company and industry specific research across technology, consumer products & retail, health care, natural resources & energy, and foreign issuers. RDI also covers companies with a smaller market capitalization, usually between $20-$100 million, that other brokerage firms may be inclined to ignore.

On Jan. 30, 2018, Corbus Pharmaceuticals announced that it had received a Development Award for up to $25 million from the Cystic Fibrosis Foundation. With the Development Award, the company plans to execute its Phase 2b study of lenabasum, formerly known as anabasum, in the treatment of cystic fibrosis patients who are 12 years in age or older.

“We believe this award highlights the potential for lenabasum to serve as an important therapy for people living with CF by targeting a critical unmet need in all CF patients. We are grateful to the CF Foundation for expanding its support for our CF clinical program, including our Phase 2b clinical development program in which the event rate of pulmonary exacerbations will be the primary efficacy endpoint,” commented Yuval Cohen, Ph.D., CEO of Corbus, in a statement.


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