Full Press Release Details
Pharmaceuticals Reports 2019 Second Quarter Financial Results and Provides Clinical and Corporate Updates
| Clinical development of lenabasum on target for 2020 data readouts in lead indications systemic sclerosis and cystic fibrosis; diseases affect 270,000 people total in U.S., EU and Japan | ||
| CRB-4001 on course to start Phase 1 study in 2019 as a candidate for NASH | ||
| Proprietary platform generates first group of pre-clinical endocannabinoid mimetic compounds | ||
| Corbus positioned to become the leader in the treatment of inflammatory, fibrotic and metabolic diseases by targeting the endocannabinoid system (ECS) | ||
| Company to host conference call and webcast today, August 8 at 8:30 a.m. ET |
MA (August 8, 2019) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"),
a clinical-stage drug development company pioneering transformative medicines that target the endocannabinoid system, today announced
its financial results for the second quarter ended June 30, 2019. The Company also provided an update on its corporate progress,
clinical status and financial position.
2019 Corporate Highlights:
| Completed subject enrollment in RESOLVE-1 Phase 3 study of lenabasum for the treatment for systemic sclerosis. Company expects to report topline results from this study in the summer of 2020. | ||
| Presented continued favorable safety and improvement in efficacy outcomes at 21 months for systemic sclerosis (SSc) and 16 months for dermatomyositis (DM) in open-label extensions of lenabasum Phase 2 studies. These data were presented at the annual European Congress of Rheumatology (EULAR 2019) conference. |
| Appointed Rachelle Jacques as a member of the Board of Directors. Ms. Jacques is CEO of Enzyvant Therapeutics, Inc. and the former Global Complement Franchise Head at Alexion Pharmaceuticals, Inc. She brings U.S. and global commercialization and marketing experience, including multiple product launches in rare diseases. | ||
| Appointed Robert Discordia, Ph.D., as Chief Operating Officer. Dr. Discordia joined the Company in May 2018, bringing >25 years of biopharmaceutical industry experience in CMC development and business operations to Corbus, most recently at Bristol-Myers Squibb. In his new role, Dr. Discordia will be responsible for optimizing the Company's operational efficiency and effectiveness, corporate planning and performance management. |
made significant progress during the second quarter as we continued to pioneer transformative medicines that target the endocannabinoid
system. We advanced our four ongoing clinical studies for lenabasum and expect to report topline data beginning in the summer
of 2020 in systemic sclerosis and cystic fibrosis. Additionally, we continue to execute on our development of CRB-4001 and expect
to enter the clinic with a Phase 1 study later this year," commented Yuval Cohen, Ph.D., Chief Executive Officer of Corbus.
"In addition to our lead assets, our team is leveraging our unique platform to generate new endocannabinoid mimetic drugs
to fuel the future growth of our pipeline and open the door to potential collaborations. We were pleased to present the first
group of these potential compounds at our recent R&D Day in June. With a number of important catalyst achievements ahead,
Corbus is well positioned to complete our clinical milestones, lay the foundation for our corporate commercialization strategy
and deliver value for our stakeholders."
- Rationally-Designed, Oral, Selective Cannabinoid Receptor Type 2 (CB2) Agonist
Sclerosis (SSc) - Phase 3 "RESOLVE-1" Study: Enrollment Complete, Topline Data Expected in Summer of 2020
| SSc is a chronic, rare systemic autoimmune disease characterized by tissue inflammation and fibrosis affecting ~200,000 people in the U.S., EU and Japan. | ||
| SSc has the highest mortality rate among the systemic autoimmune diseases. | ||
| Data from the Phase 2 open-label extension was recently presented at the annual EULAR 2019 conference and showed continued favorable safety and durable improvement in efficacy outcomes: |
| ACR CRISS score remains 0.95 (95%) at 21 months in systemic sclerosis open-label extension (OLE) study | ||
| 81% systemic sclerosis subjects remain on lenabasum in the OLE 21 months | ||
| No serious or severe AEs related to lenabasum reported in the study to date |
has enrolled 365 individuals with SSc in an international, multicenter, randomized, double-blind, placebo-controlled study that
is being conducted in North America, Europe, Israel, Japan, South Korea and Australia. Corbus expects to report topline results
from the study in the summer of 2020, with commercialization in 2021 following potential U.S. FDA approval. Lenabasum was granted
Orphan Drug Designation for the treatment of SSc from the U.S. FDA and the European Medicines Agency (EMA) and granted Fast Track
status from the FDA. For more information on the Phase 3 study, please visit ClinicalTrials.gov and reference Identifier
(DM) - Phase 3 "DETERMINE" Study Underway, Topline Data Expected in 2021
| DM is a rare and serious autoimmune disease characterized by skin and muscle inflammation affecting ~ 80,000 people in the U.S., EU and Japan. Five-year mortality is as high as 30%. | ||
| Enrollment is ongoing in 150 patient Phase 3 study with the American College of Rheumatology/European League Against Rheumatism 2016 Total Improvement Score in myositis as the primary efficacy endpoint. | ||
| Data from the Phase 2 open-label extension was recently presented at the annual EULAR 2019 conference and showed continued favorable safety and durable improvement in efficacy outcomes: |
| CDASI activity score reached -21.8 points at 16 months in dermatomyositis OLE study | ||
| 90% dermatomyositis subjects remain in OLE at 16 months | ||
| No serious or severe AEs related to lenabasum reported in the study to date |
was granted Orphan Drug Designation for the treatment of DM from the U.S. FDA and EMA. For more information on the Phase 3 study,
please visit ClinicalTrials.gov and reference Identifier NCT03813160.
Fibrosis (CF) - Phase 2b Study Underway, supported by a Development Award for up to $25 Million from the Cystic Fibrosis
Foundation, Topline Data Expected in Summer of 2020
| CF is a life-threatening genetic disease characterized in part by chronic lung inflammation that leads to lung damage and fibrosis. CF affects ~70,000 people in U.S. and EU. | ||
| Enrollment and dosing are ongoing in the 415 patient Phase 2b study with the event rate of pulmonary exacerbations (PEx) as the primary efficacy endpoint. Pulmonary exacerbations are a clinically relevant event of worsening of respiratory symptoms usually accompanied by an acute decrease in lung function and an increase in lung inflammation. | ||
| Pulmonary exacerbations are responsible for about half of long-term decline in lung function experienced by people with CF. | ||
| There continues to be an unmet need for drugs that reduce rate and severity of PEx in people with CF. |
was granted Orphan Drug Designation for the treatment of CF from the U.S. FDA and the EMA and granted Fast Track status from the
FDA. For more information on the Phase 2b study, please visit ClinicalTrials.gov and reference Identifier NCT03451045.
Lupus Erythematosus (SLE) - Phase 2 Study Underway, Represents the Largest Potential Patient Population Targeted by Lenabasum,
Topline Data Expected in 2020
| Enrollment and dosing are ongoing in 100 patient Phase 2 study being conducted and funded by the National Institutes of Health (NIH). | ||
| SLE is a severe and sometimes life-threatening systemic autoimmune disease affecting approximately 550,000 people in the U.S., EU and Japan. | ||
| Disease pathology can include inflammation in many different organs, including the kidneys and brain. | ||
| People with SLE continue to have high unmet medical need as standard-of-care often includes immunosuppressive drugs, which can have significant side effects. |
more information on the Phase 2 study of lenabasum for the treatment of SLE, please visit ClinicalTrials.gov and reference
Identifier NCT03093402.
is not approved for the treatment of systemic sclerosis, dermatomyositis, cystic fibrosis or systemic lupus erythematosus.
- 2nd Generation, Selective Cannabinoid Receptor Type 1 (CB1) Inverse Agonist Targeting Liver Fibrosis, Designed to be Peripherally
is rationally designed to be an inverse agonist of cannabinoid receptor type 1. It has been designed to improve certain metabolic
abnormalities in people with nonalcoholic steatohepatitis (NASH), while reducing inflammation and fibrosis in the liver. Preparations
are underway to begin a Phase 1 study of CRB-4001 by the end of 2019. We expect this to be followed by an NIH-funded study of
blood brain barrier penetration by CRB-4001, then a biomarker study in people with metabolic syndrome or NASH.
is not approved for the treatment of NASH.
the Future Growth of the Clinical Pipeline - Library of >700 Unique Early Stage Drug Compounds Targeting the Endocannabinoid
is actively leveraging its proprietary library of >700 unique early stage compounds to develop endocannabinoid mimetics targeting
inflammatory, fibrotic, and metabolic diseases. The Company recently introduced its first group of compounds, including both novel
CB2 agonists and novel CB1 inverse agonists, generated from its proprietary platform at its R&D day hosted on June 21, 2019
in New York. The compounds are structurally distinct, and each has so far generated a unique profile of effects on inflammation
plans to continue exploring the potential of its proprietary platform and advance its library of early stage compounds by transitioning
to animal models, selecting initial indications and routes of administration, as well as establishing partnerships with pharmaceutical
partners where applicable.
of Financial Results for Second Quarter 2019 Ended June 30, 2019
the quarter ended June 30, 2019, the Company reported net income of approximately $2,153,000 or net income per diluted share of
$0.03, compared to a net loss of approximately $12,100,000, or a net loss per diluted share of $0.21, for the quarter ended June
For the quarter ended June 30, 2019, revenue from awards increased by approximately $1.2 million to $2.1 million due to revenue
recognized from the Development Award Agreement with the Cystic Fibrosis Foundation. Revenue for the quarter ended June 30, 2019
also included $27 million from the up-front licensing payment received from Kaken Pharmaceuticals in March 2019.
expenses for the quarter ended June 30, 2019 increased by approximately $14.1 million to $27.4 million. The increase was attributable
to increased spending for clinical studies, the costs to manufacture and supply lenabasum for clinical trials, staffing costs,
a $1.0 million increase in non-cash stock compensation expenses and a $2.7 million sub-royalty payment paid to the CF Foundation
as a result of the $27 million up-front licensing payment received from Kaken Pharmaceuticals.
Company ended the quarter with $73.2 million in cash and cash equivalents. The Company expects the current cash and cash equivalents
together with the $7.5 million remainder of the expected milestone payments from the up to $25 million Development Award from
the Cystic Fibrosis Foundation to fund operations into the fourth quarter of 2020, based on current planned expenditures.
Call and Webcast Information
management will host a conference call and webcast presentation for investors, analysts and other interested parties today, Thursday,
August 8 at 8:30 a.m. ET.
participate in the call, please dial (877) 407-3978 (domestic) or (412) 902-0039 (international). The live webcast will
be accessible on the Events page of the Investors section of the Corbus website, www.corbuspharma.com, and
will be archived for 90 days.
is a rationally designed, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2) and
has been designed to resolve inflammation, limit fibrosis and support tissue repair. CB2 is preferentially expressed on activated
immune cells and on fibroblasts, muscle cells, and endothelial cells. In both animal and human studies conducted to date, lenabasum
has induced the production of pro-resolving lipid mediators that activate endogenous pathways which resolve inflammation and speed
bacterial clearance without immunosuppression. Data from animal models and human clinical studies suggest that lenabasum can reduce
expression of genes and proteins involved in inflammation and fibrosis. Lenabasum has demonstrated promising activity in animal
models of skin and lung inflammation and fibrosis in systemic sclerosis (SSc). Lenabasum is also active in animal models of lung
infection and inflammation in cystic fibrosis and joint inflammation and scarring in rheumatoid arthritis.
has demonstrated an acceptable safety and tolerability profiles in clinical studies to date. Lenabasum treatment was associated
with improvement in multiple physician-assessed and patient-reported efficacy outcomes in Phase 2 studies in patients with diffuse
cutaneous SSc and patients with DM with active skin involvement but not currently active muscle involvement. Lenabasum treatment
also was associated with a lower rate of and longer time to pulmonary exacerbations in a Phase 2 cystic fibrosis study. Additional
clinical studies are being conducted to confirm these results and support applications for regulatory approval.
is a 2nd generation, selective cannabinoid receptor type 1 (CB1) inverse agonist designed to be peripherally restricted. Preclinical
data show CRB-4001 improves inflammation and has multiple effects on metabolic function relevant to the treatment of nonalcoholic
steatohepatitis (NASH). CRB-4001 was developed in collaboration with and financial support from the National Institutes of Health
(NIH). CRB-4001 was specifically designed to eliminate blood-brain barrier penetration and brain CB1 receptor occupancy that mediate
the neuropsychiatric issues associated with first-generation CB1 inverse agonists such as rimonabant. Corbus expects to initiate
a Phase 1 study for CRB-4001 in 2019. We expect this to be followed by an NIH-funded study of blood brain barrier penetration
by CRB-4001, then a biomarker study in people with metabolic syndrome or NASH.
Pharmaceuticals Holdings, Inc. is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization
of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its pipeline of endocannabinoid system-targeting
synthetic drug candidates. The Company's lead product candidate, lenabasum, is a novel, synthetic, oral, selective cannabinoid
receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated