Corbus Pharmaceuticals Reports 2018 First Quarter Financial Results and Provides Business Update - Company continues to make consistent progress in the clinical development programs of lenabasum, in rare, chronic and ser

Pharmaceuticals Reports 2018 First Quarter Financial Results and Provides Business Update

Company continues to make consistent progress in the clinical development programs of lenabasum, in rare, chronic and serious

inflammatory and fibrotic diseases -

MA (May 10, 2018) - Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"),

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, announced today its financial results for the first quarter ended

Company also provided an update on its corporate progress, clinical status and anticipated milestones for lenabasum, its novel

synthetic oral endocannabinoid-mimetic drug designed to resolve chronic inflammation and halt fibrosis in rare autoimmune and

inflammatory diseases.

Clinical and Corporate Highlights

continued to make progress in the first quarter of 2018 in all four of our clinical programs: systemic sclerosis, cystic fibrosis,

dermatomyositis and lupus. We look forward to achieving a number of additional important milestones this year," stated Yuval

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

Sclerosis Clinical Program Update

sclerosis is a serious autoimmune disease affecting approximately 90,000 people in the US and Europe and is associated with significant

morbidity and up to 60% 10-year mortality. There are currently no drugs specifically approved by the FDA for treatment of systemic

dosing is ongoing in the Phase 3 ("RESOLVE-1") study of lenabasum for the treatment of diffuse cutaneous systemic

sclerosis ("systemic sclerosis"). The international, multicenter Phase 3 RESOLVE-1 study is a double-blind, randomized,

placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of systemic sclerosis. The study will

enroll approximately 354 subjects at 70 sites in North America, Europe, Israel, Japan, South Korea and Australia. The planned

duration of treatment with study drug is 52 weeks. Subjects are randomized 1:1:1 to receive lenabasum 5 mg twice per day, lenabasum

20 mg twice per day or placebo twice per day.

primary efficacy outcome of the RESOLVE-1 study will be change from baseline in modified Rodnan Skin Score ("mRSS"),

a measure of skin fibrosis and a standard clinical trial outcome in systemic sclerosis. Secondary outcomes of the RESOLVE-1 study

include patient- and physician-reported outcomes, forced vital capacity, the American College of Rheumatology Combined Response

Index in diffuse cutaneous Systemic Sclerosis ("ACR CRISS") score, a novel composite measure of clinical improvement

from baseline that incorporates change from baseline in mRSS, and lung function. These same outcomes were measured in the Phase

2 study as well as the follow-on open-label extension study for which the 28-week results in all of these efficacy measures were

presented in November 2017 at the American College of Rheumatology conference. For more information on the Phase 3 study, please

visit ClinicalTrials.gov and reference Identifier NCT03398837.

expects to report topline results from the Phase 3 RESOLVE-1 study in the first half of 2020 and will provide regular updates

from the ongoing open-label extension study.

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

Designation from the European Medicines Agency ("EMA").

Fibrosis ("CF") Clinical Program Update

fibrosis is a chronic, life-threatening, genetic rare disease, characterized by chronic lung inflammation that leads to lung damage

and fibrosis that affects approximately 30,000 patients in the U.S and 75,000 patients worldwide. The current average life expectancy

for CF patients is 40 years. The harmful inflammation and accompanying fibrosis in CF damages multiple organs, impairs organ function,

reduces health-related quality of life, and is the most common cause of mortality. There remains a recognized unmet need for safe

and effective drugs that target chronic inflammation and fibrosis for the treatment of CF on top of standard of care but without

the risk of immunosuppression currently associated with existing anti-inflammatory drugs.

has commenced its Phase 2b study evaluating lenabasum for the treatment of CF. This Phase 2b CF study was designed with input

from the Therapeutic Development Network of the Cystic Fibrosis Foundation and the European Cystic Fibrosis Society Clinical Trials

Network and is supported by a Development Award for up to $25 million from the Cystic Fibrosis Foundation.

Phase 2b multicenter, double-blinded, randomized, placebo-controlled study will enroll approximately 415 subjects with CF who

are at least 12 years of age and at increased risk for pulmonary exacerbations. Secondary efficacy outcomes include other measures

of pulmonary exacerbations, change in Cystic Fibrosis Questionnaire-Revised Respiratory domain score and change in forced expiratory

volume in 1 second ("FEV1"), % predicted. The study will be conducted in approximately 100 sites across North America,

Europe and Australia. Subjects are centrally randomized to one of three cohorts to receive lenabasum 20 mg twice per day, lenabasum

5 mg twice per day, or placebo twice per day for 28 weeks, with 4 weeks follow-up off active treatment. For more information on

the Phase 2b study, please visit ClinicalTrials.gov and reference Identifier NCT03451045.

expects to report topline results for the Phase 2b CF study in the first half of 2020.

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

Clinical Program Update

is a rare and serious systemic autoimmune condition characterized by skin and muscle inflammation that affects as many as 70,000

people in the US. Mortality is high with 5-year survival of 70% and 10-year survival of 57%. Current standard of care includes

antimalarial drugs and potent immunosuppressive agents, which often lead to significant adverse effects.

October 2017, Corbus announced positive topline results from its Phase 2 study evaluating lenabasum for the treatment of skin-predominant

dermatomyositis, demonstrating medically and statistically significant improvement in the Cutaneous Dermatomyositis Disease Area

and Severity Index ("CDASI"), the primary endpoint in the study. Significant improvements were also seen in multiple

secondary patient-reported outcomes. The Company plans to meet with the FDA in this quarter to discuss the next clinical study

of lenabasum for the treatment of DM, which is expected to begin by the end of 2018.

Lupus Erythematosus ("SLE") Clinical Program Update

is a prototypical autoimmune disease in which the innate immune system is chronically activated by immune complexes containing

autoantibodies and self-antigens, which leads to widespread inflammation and tissue damage. According to the CDC, SLE affects

between 161,000 - 322,000 people in the US and has many manifestations, including arthritis, rash, photosensitivity, oral ulcers,

pleuritis, pericarditis, kidney problems, seizures and psychosis and blood cell abnormalities. Current drugs specifically approved

by the FDA for SLE are limited to aspirin, corticosteroids, hydroxychloroquine and belimumab. Physicians commonly treat disease

manifestations with immunosuppressive or corticosteroid therapies that have significant toxicities.

dosing has commenced in the Phase 2 randomized, double-blind, placebo-controlled, clinical study evaluating lenabasum for the

treatment of systemic lupus erythematosus which is being conducted by the Autoimmunity Centers of Excellence ("ACE")

and is being funded by The National Institutes of Health. The trial will enroll 100 adult SLE patients with active musculoskeletal

disease, which is the most common disease manifestation of SLE. Subjects are randomized in a 1:1:1:1 ratio to one of four cohorts

to receive placebo or three different doses of lenabasum for 3 months, with 1-month of follow-up. The primary efficacy outcome

assesses pain from active musculoskeletal disease, and secondary efficacy outcomes include other assessments of active musculoskeletal

disease, overall disease activity using SLE Responder Index, SLE Disease Activity Index ("SLEDAI") and British Isles

Lupus Activity Group ("BILAG") scoring systems, and patient-reported outcomes.

more information on the Phase 2 study of lenabasum for the treatment of SLE, please visit ClinicalTrials.gov and reference

Identifier NCT03093402.

of Financial Results for First Quarter 2018

the quarter ended March 31, 2018, the Company reported a net loss of approximately $11,695,000 or a net loss per diluted share

of $0.21, compared to a net loss of approximately $7,465,000, or a net loss per diluted share of $0.16, for the quarter ended

for the quarter decreased by approximately $0.3 million to $1.0 million from the quarter ended March 31, 2017. Revenue recognized

in 2018 was related to the up to $25 million Development Award Agreement with the Cystic Fibrosis Foundation that the Company

entered into in the first quarter of 2018. Operating expenses for the quarter increased by approximately $4.1 million to $12.8

million due to increased spending for clinical studies, manufacturing costs to produce lenabasum for clinical studies and staffing

Company ended the first quarter with approximately $71.0 million of cash and cash equivalents, an increase of $8.4 million from

the start of the quarter. The Company received $6.25 million in milestone payments from the Cystic Fibrosis Foundation during

the first quarter and raised approximately $11.2 million in net proceeds from the sale of common stock. The Company expects the

current cash and cash equivalents together with the expected milestone payments from the up to $25 million Development Award from

the Cystic Fibrosis Foundation to fund operations through the fourth quarter of 2019, based on current planned expenditures.

(formerly known as anabasum) is a synthetic, oral, small-molecule, selective cannabinoid receptor type 2 (CB2) agonist that preferentially

binds to CB2 expressed on activated immune cells and fibroblasts. CB2 activation triggers physiologic pathways that resolve inflammation,

speed bacterial clearance and halt fibrosis. CB2 activation also induces 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. Through activation of CB2, lenabasum also is designed to have a direct effect on fibroblasts

to halt tissue scarring. Lenabasum is believed to induce resolution rather than immunosuppression by triggering biological pathways

to turn "off" chronic inflammation and fibrotic processes. Lenabasum has demonstrated promising potency in preclinical

models of inflammation and fibrosis. Preclinical and human clinical studies have shown lenabasum to have a favorable safety, tolerability