Corbus Pharmaceuticals Reports 2017 First Quarter Financial Results and Provides Business Update - Q1 2017 marked by positive data from Phase 2 study of anabasum for the treatment of cystic fibrosis - - Company ended the

Pharmaceuticals Reports 2017 First Quarter Financial Results and Provides Business Update

Q1 2017 marked by positive data from Phase 2 study of anabasum for the treatment of cystic fibrosis -

Company ended the quarter with $49 million of cash which is sufficient to fund operations through the end of 2018 -

MA (May 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 first quarter ended March 31, 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 in both the corporate and clinical areas in the first quarter of 2017 and are in a strong financial

position, which is expected to take us through key milestones for the Company over the next 20 months," stated Yuval

Cohen, Ph.D., Chief Executive Officer of the Company.

Sclerosis Clinical Program Update

Corbus reported positive topline data results

from a Phase 2 study in diffuse cutaneous systemic sclerosis ("systemic sclerosis") in November 2016, showing

a clear signal of clinical benefit with anabasum. The 12-month open-label extension of this Phase 2 study is ongoing and is designed

to capture long-term safety and efficacy data in subjects dosed with anabasum 20 mg twice per day. To date, subjects have been

safely dosed with anabasum for up to 10 months and Corbus intends to present data at the 2017 American College of Rheumatology

("ACR") Annual Meeting.

an end-of-Phase 2 meeting with the U.S. Food and Drug Administration ("FDA"), Corbus submitted a protocol to the FDA

for its Phase 3 study in systemic sclerosis on March 31, 2017, and is moving forward as planned. We expect to commence

this study in the fourth quarter of 2017. Protocol assistance from the European Medicines Agency ("EMA") on

the Phase 3 study design is expected in the second quarter of 2017.

planned Phase 3 study is a double-blind, randomized, placebo-controlled, parallel dose, multi-center study to be

conducted in approximately 270 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 planned Phase 3 study will be change from baseline at Week 52 in modified Rodnan Skin Score

("mRSS"), a measure of skin thickening and a validated clinical outcome measure in systemic sclerosis. Topline

results of the Phase 2 study showed that the mean improvement from baseline in mRSS for anabasum-treated subjects was greater

than for the placebo-treated subjects, and considered medically meaningful. The improvement in mRSS was accompanied by

statistically significant improvement in the anabasum arm in patient-reported skin symptoms and reduced expression of

genes associated with inflammation and fibrosis in skin biopsies. The Company expects to complete enrollment of the 52-week

study in 2018. The Company also expects results by the end of 2019 and a New Drug Application ("NDA") application

to be filed in 2020.

was granted Orphan Drug Designation and Fast Track status for the treatment of systemic sclerosis from the FDA in

2015 and Orphan Designation from the European Medicines Agency ("EMA") in January 2017. The Company was not

granted Breakthrough Designation for systemic sclerosis, however Corbus' existing Fast Track status already grants it similar

eligibility for more frequent meetings with the FDA to discuss the development plan for anabasum, as well as Priority Review

and Rolling Reviews of completed sections of the NDA.

Near-Term Milestones:

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 had an acceptable safety and tolerability

profile, reduced pulmonary exacerbations treated with antibiotics, and reduced multiple inflammatory biomarkers in sputum collected

from subjects in the study. The 16-week study was an international, multi-center study supported by a $5 million Development

Award from Cystic Fibrosis Foundation Therapeutics, Inc.

successfully achieved the primary objective of the study by demonstrating an acceptable safety and tolerability profile with no

serious or severe adverse events related to the study drug. Anabasum cohorts showed a reduction in a number (event rate per subject)

of pulmonary exacerbations treated with intravenous antibiotics compared to placebo, which was a prespecified event of special

interest in the protocol, as well as the number (event rate per subject) of pulmonary exacerbations treated with any new antibiotic.

Patients in the highest dose cohort of anabasum (20 mg orally, twice per day) had a 75% reduction in the annualized rate of pulmonary

exacerbations requiring IV antibiotics compared to placebo cohort. Forced expiratory volume in 1 second (FEV1) remained stable

throughout the study in all treatment cohorts.

Additionally, patients receiving anabasum

showed a reduction in multiple inflammatory cell types in sputum, including total leukocytes, neutrophils, eosinophils,

and macrophages. Also, a dose-dependent reduction in sputum inflammatory mediators, including interleukin-8, neutrophil

elastase, and immunoglobulin G was observed. These data provide evidence of pharmacologic activity of anabasum at resolving

ongoing innate immune responses in lungs of CF patients and support the potential of anabasum to reduce in pulmonary exacerbations

was granted Orphan Drug Designation and Fast Track status for the treatment of CF by the FDA in 2015 and Orphan Designation

from the EMA in 2016.

Near-Term Milestones:

Clinical Program Update

is currently evaluating anabasum in an on-going Phase 2 study for the treatment of skin-predominant dermatomyositis. In

November 2016, the Company commenced a one-year, open-label extension to provide all enrolled subjects in the Phase 2 study

with the option of receiving anabasum for one year after they complete the four-month, double-blind placebo controlled portion

Phase 2 study in skin-predominant dermatomyositis is being funded by a grant from the National Institute of Arthritis and Musculoskeletal

and Skin Diseases of the National Institutes of Health to the University of Pennsylvania School of Medicine. 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:

Lupus Erythematosus Clinical Program Update

expects the National Institutes of Health ("NIH")-funded and operationally-executed Phase 2 clinical study evaluating

anabasum for the treatment of Systemic Lupus Erythematosus ("SLE") to begin in the second half of 2017. The

Phase 2 SLE study will evaluate anabasum at doses of 5 mg, 20 mg, and 20 mg twice daily, administered orally for 12 weeks, with

1 month follow-up, at approximately 12 U.S. sites.

are very pleased with our progress in the clinical development of anabasum over the past two years, advancing this experimental

drug into multiple first-in-patient studies in serious chronic indications with high unmet medical needs, two of which have delivered

positive clinical data and are moving ahead to their next stages of clinical development by year end," concluded Dr. Cohen.

of Financial Results for First Quarter 2017

the quarter ended March 31, 2017, the Company reported a net loss of approximately $7,465,000, or a net loss per diluted share

of $0.16, compared to a net loss of approximately $2,892,000, or a net loss per diluted share of $0.08 for the quarter ended March

revenue for the quarter increased by approximately $0.9 million to $1.3 million due to revenue recognized from the $5 million

development award received from the Cystic Fibrosis Foundation Therapeutics, Inc. Operating expenses increased by approximately

$5.4 million to $8.7 million due to increased spending for clinical studies, manufacturing costs to produce anabasum for clinical

studies and staffing costs.

Company ended the first quarter with $48.9 million of cash and cash equivalents, an increase of $33.9 million from the start of

the quarter. The Company raised $41 million of capital during the first quarter including the following:

Company expects the cash on hand to fund operations through 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 clinical stage pharmaceutical company focused on the development and commercialization of