Recent Updates
Recently added Catalysts
CRBP

Corbus Pharmaceuticals Reports 2017 Second Quarter Financial Results and Provides Business Update - Data from Phase 2 open-label extension study of anabasum for the treatment of systemic sclerosis expected in Q4 2017 - -

Key Takeaway: Pharmaceuticals Reports 2017 Second Quarter Financial Results and Provides Business Update Data from Phase 2 open-label extension study of anabasum for the treatment of systemic sclerosis expected in Q4 2017 - Phase 3 study of anabasum for the treatment of system sclerosis expe

Full Press Release Details

Pharmaceuticals Reports 2017 Second Quarter Financial Results and Provides Business Update
Data from Phase 2 open-label extension study of anabasum for the treatment of systemic sclerosis expected in Q4 2017 -
Phase 3 study of anabasum for the treatment of system sclerosis expected to commence in Q4 2017 -
Topline data from Phase 2 study of anabasum in skin-predominant dermatomyositis expected to be reported in Q4 2017 -
MA (August 9, 2017) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"),
a clinical stage drug development company targeting rare, chronic, serious inflammatory and fibrotic diseases, announced today
its financial results for the second quarter ended June 30, 2017.
Company also provided an update to its corporate progress, clinical status and anticipated milestones for anabasum, its
novel synthetic oral endocannabinoid-mimetic drug that is designed to resolve chronic inflammation and halt fibrosis.
have made significant progress on the corporate, operational and clinical fronts, enabling the Company to move forward with a
strong balance sheet and plans to execute on multiple potentially impactful milestones coming up in the second half of this year,"
stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company.
Sclerosis Clinical Program Update
an end-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA") and a protocol assistance meeting with
the European Medicines Agency ("EMA"), Corbus plans to commence a Phase 3 study of anabasum for the treatment of
systemic sclerosis in the fourth quarter of 2017.
international Phase 3 study is a double-blind, randomized, placebo-controlled, parallel dose, multi-center study that will be
conducted in approximately 350 adults with diffuse cutaneous systemic sclerosis. Subjects will be randomized to
receive anabasum 20 mg twice per day, anabasum 5 mg twice per day, or placebo twice per day for 52 weeks. The primary
efficacy outcome of the Phase 3 study will be change from baseline at week 52 in modified Rodnan Skin Score
("mRSS"), a measure of skin fibrosis and thickening in systemic sclerosis. The Company expects to conclude this
pivotal Phase 3 study by the end of 2019.
November 2016, the Company reported positive topline data from its Phase 2 study in systemic sclerosis. The Company reported that
anabasum outperformed placebo in the mRSS, the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic
Sclerosis ("ACR CRISS") and multiple individual core measures in the ACR CRISS. In June 2017, at the European League
Against Rheumatism ("EULAR") Annual Meeting, the Company presented additional supportive clinical and translational
data including patient-reported outcomes and gene transcript analysis from skin biopsies. On August 7, 2017, Corbus presented
histology data from the Phase 2 study at the 15th International Workshop on Scleroderma Research demonstrating significant reductions
in inflammation and fibrosis in skin biopsies of patients who received anabasum versus placebo. These data provide further evidence
for a direct, on-target effect of anabasum in resolution of innate immune responses and correspond with mRSS benefit seen in the
has been granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the
FDA and Orphan Designation from the EMA.
the Company is conducting an open-label extension study in systemic sclerosis as a continuation of the Phase 2 study. The open-label
study began enrolling subjects in September 2016 and a majority of the Phase 2 study patient participants are enrolled in this
open-label extension study. The open-label extension has been extended from one year to two years' duration.
Near-Term Milestones:
Present data from the Phase 2 open-label extension study in Q4 2017; and
Commence Phase 3 systemic sclerosis study in Q4 2017.
Fibrosis Clinical Program Update
March 2017, Corbus reported positive topline data from the double-blind, randomized, placebo-controlled Phase 2 study of
anabasum for the treatment of cystic fibrosis ("CF") showing that anabasum, compared to placebo, reduced the
rate of pulmonary exacerbations treated with antibiotics, reduced multiple inflammatory biomarkers and had an acceptable safety
and tolerability profile. The 16-week study was an international, multi-center study supported by a $5 million Development
Award from Cystic Fibrosis Foundation Therapeutics, Inc. Data from this study was presented at the European Cystic Fibrosis Society
("ECFS") conference in June 2017 and also will be presented at the North American Cystic Fibrosis Conference ("NACFC")
has been granted Orphan Drug Designation and Fast Track status for the treatment of CF by the FDA and Orphan Designation
Near-Term Milestones:
Present Phase 2 CF clinical results at NACFC in November 2017;
Conclude Phase 2b CF study protocol design in collaboration with the Cystic Fibrosis Foundation Therapeutic Development Network;
Obtain guidance from the FDA and EMA on protocol design for the Phase 2b CF study;
Submit Pediatric Investigational Plan to EMA; and
Planning to initiate the Phase 2b clinical study by the end of 2017.
Clinical Program Update
is currently evaluating anabasum in an on-going Phase 2 study for the treatment of skin-predominant dermatomyositis. Enrollment
was completed in May 2017. In November 2016, the Company commenced a one-year, open-label extension to provide subjects
in the Phase 2 study with the option of continuing anabasum treatment beyond their completion of the four-month, double-blind
placebo controlled portion of the study. Corbus expects to report topline data from the Phase 2 study in Q4 2017.
primary objectives of the Phase 2 study are to evaluate anabasum's safety, tolerability, and clinical efficacy in up to 22 adult
subjects with moderate to severe skin-predominant dermatomyositis that is refractory to standard-of-care. Efficacy will be assessed
using the Cutaneous Dermatomyositis Disease Area and Severity Index activity score ("CDASI"), a validated measure of
skin disease activity in dermatomyositis. Secondary objectives include evaluating anabasum's effects on quality of life
with the Skindex-29+3 questionnaire and the PROMIS-29 Short Form, as well as on skin and blood biomarkers of inflammation. Study
subjects are treated with anabasum for 84 days, with a follow-up period of 28 days.
single-center, Phase 2 study in skin-predominant dermatomyositis is being conducted at the University of Pennsylvania School of
Medicine and is funded by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National
Institutes of Health ("NIH"). For more information on the Phase 2 study with anabasum for the treatment of skin-predominant
dermatomyositis, please visit ClinicalTrials.gov and reference Identifier NCT02466243.
Near-Term Milestones:
Report topline data from Phase 2 DM study early in Q4 2017; and
Continue ongoing Phase 2 open-label extension study.
Lupus Erythematosus Clinical Program Update
expects that the Phase 2 clinical study evaluating anabasum for the treatment of systemic lupus erythematosus ("SLE"),
which will be funded by the NIH and will be operationally-executed by the NIH, will begin in the fourth quarter of 2017. The Phase
2 SLE study will evaluate anabasum in 100 patients at doses of 5 mg, 20 mg, and 20 mg twice daily, administered orally for 12
weeks, with 28 days follow-up, at approximately 14 U.S. sites.
of Financial Results for Second Quarter 2017
the quarter ended June 30, 2017, the Company reported a net loss of approximately $7,297,000, or a net loss per diluted share
of $0.15, compared to a net loss of approximately $4,189,000, or a net loss per diluted share of $0.11 for the quarter ended June
expenses increased by approximately $3.1 million to $7.6 million due to increased spending for clinical studies, manufacturing
costs to produce anabasum for clinical studies stock compensation expense and staffing costs.
Company ended the second quarter with approximately $43.0 million of cash and cash equivalents, and expects the cash on hand to
fund operations into the fourth quarter of 2018, based on current planned expenditures.
is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune
cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Preclinical and
human clinical studies have shown anabasum to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated
promising potency in preclinical models of inflammation and fibrosis. Anabasum is designed to trigger the production of "Specialized
Pro-resolving Lipid Mediators" that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis,
while reducing production of multiple inflammatory mediators. Anabasum also is designed to have direct effects on fibroblasts
to halt tissue scarring. In effect, anabasum triggers endogenous pathways to turn "off" chronic inflammation and fibrotic
processes, without causing immunosuppression
Pharmaceuticals Holdings, Inc. is a Phase 3 clinical stage pharmaceutical company focused on the development and commercialization
of novel therapeutics to treat rare, chronic, and serious inflammatory and fibrotic diseases. The Company's lead product candidate,
anabasum, is a novel synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and fibrotic processes.
Anabasum has demonstrated positive results in two Phase 2 studies, one in diffuse cutaneous systemic sclerosis and one in cystic
fibrosis. Additionally, anabasum is being evaluated in open-label extension studies in systemic sclerosis and skin-predominant
dermatomyositis, and soon in another Phase 2 study in systemic lupus erythematosus.
plans to commence a Phase 3 study of anabasum for the treatment of systemic sclerosis in the fourth quarter of 2017. The Company
is also planning to initiate a larger and longer Phase 2b study of anabasum for the treatment of cystic fibrosis by the end of
the fourth quarter of 2017.
more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+
press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating
to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, possible or
assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive
in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the
industry and markets in which we operate and management's current beliefs and assumptions.
Last updated: Aug 9, 2017