 RESOLVE-1 Phase 3 study of lenabasum for treatment of systemic sclerosis on schedule for topline data this summer Phase 2b study of lenabasum for cystic fibrosis topline results on schedule in Q3 2020 Balance sheet strengthened with up to 121M in new capital Company to host conference call and webcast today, August 6, 2020 at 8:30 a.m. ETNorwood, MA, Aug. 06, 2020 GLOBE NEWSWIRE -- 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 reported financial results for the second quarter of 2020. The Company also provided clinical and corporate updates.We had a busy second quarter as we prepare for a potentially transformative second half of the year with two expected data readouts, including topline data in our Phase 3 study for systemic sclerosis this summer, followed by our Phase 2b study in cystic fibrosis. We recently announced that we completed sales of 71 million through our ATM program and entered a debt financing agreement for up to 50 million with the first 20 million already received, strengthening our balance sheet and putting us in a solid financial position before topline data, said Yuval Cohen, Ph.D., Chief Executive Officer. We have also appointed a new board member, Dr. George Golumbeski who brings considerable expertise in corporate and business development. With these recent updates, a strong balance sheet and the critical data readouts now closer than ever, we continue to prepare the groundwork for NDA submission and commercialization following potential FDA approval.Recent Corporate Highlights and Achievements: Strengthened the Companys balance sheet with up to 121 million in new capital, bolstering its strategic flexibility. The Company received an aggregate of 71 million in gross proceeds from its at-the-market offering coupled with the execution of a 50 million debt financing facility with K2 HealthVentures, a healthcare-focused specialty finance company. In July, Corbus announced the appointment of George Golumbeski, Ph.D., to its Board of Directors. Dr. Golumbeski brings years of industry experience with a track record of growing companies and advancing innovation. During his corporate career, Dr. Golumbeski held senior leadership positions in business development at Celgene, Novartis, Elan Pharmaceuticals and Schwarz Pharma. The Company presented at several conferences during the second quarter. In May, Corbus announced the publication of two abstracts at the European League Against Rheumatism EULAR 2020 E-Congress. The first abstract highlighted pre-clinical data suggesting that biologic effects of lenabasum include inhibition of inflammasome activation. The second abstract outlined baseline characteristics of RESOLVE-1 patients in the European Union. Additionally, new data from the lenabasum Phase 2 open-label extension study were presented at the 6th Systemic Sclerosis World E-Congress. Analyses show the American College of Rheumatology Combined Response Index in diffuse cutaneous Systemic Sclerosis ACR CRISS score correlates with improvements from baseline in how patients feel and function. The presentations are available in the Scientific Conferences section of Corbus website. In June, the Company announced the publication of baseline patient demographics and disease characteristics in its Phase 2b study of lenabasum in cystic fibrosis. The information was published in an electronic supplement of the Journal of Cystic Fibrosis in connection with the 43rd European Cystic Fibrosis Conference. Lenabasum recently received Orphan Drug Designation for systemic sclerosis from Japans PMDA. Clinical Program Updates:Lenabasum: a novel, oral, selective cannabinoid receptor type 2 CB2 agonist Systemic Sclerosis SSc Last subject visit in RESOLVE-1 Phase 3 study of lenabasum for treatment of systemic sclerosis was announced on May 27. Topline results in SSc, a rare disease and the most lethal of the systemic autoimmune diseases, remain on track for this summer. The multicenter study of 365 patients is randomized 1:1:1 for twice a day dosing of lenabasum at 5 mg, 20 mg, or placebo for 52 weeks, with a 4-week follow up. The primary endpoint is the ACR CRISS score. The open-label extension of this study is active. There are no FDA-approved therapies for the overall treatment of SSc. Cystic Fibrosis CF Last subject visit in Phase 2b study of lenabasum for CF was announced on June 22. Phase 2b topline results of lenabasum in patients with CF who are at high-risk for recurrent pulmonary exacerbation will follow the RESOLVE-1 data results in the third quarter of 2020. The multicenter study of 425 patients is randomized 1:2:2 for twice a day dosing of lenabasum at 5 mg, 20 mg, or placebo for 28 weeks, with a 4-week follow up. The primary endpoint is event rate of pulmonary exacerbation PEx. Treatment of inflammation to reduce PEx remains a key unmet need in CF. Dermatomyositis DM Phase 3 DETERMINE study in DM, a rare and life-threatening autoimmune disease characterized by skin and muscle inflammation, is ongoing. Last subjects first visit in the double-blind, randomized, placebo controlled, multinational DETERMINE study of lenabasum DM was announced on August 5 with 176 subjects enrolled, with topline data expected in the fourth quarter of 2021. The primary endpoint is ACR EULAR 2016 Total Improvement Score TIS in Adult Dermatomyositis Polymyositis. The open-label extension of this study is active. There is significant unmet need for new treatments to achieve disease control in DM because of limited efficacy or toxicity of immunosuppressive agents or refractory disease. Systemic Lupus Erythematosus SLE Phase 2b study is ongoing. The study, funded and managed by the National Institutes of Health NIH, is enrolling at 15 sites in the U.S., with enrollment expected to be completed by end of this year or early 2021. CRB-4001: a peripherally restricted CB1 inverse agonist and additional candidate compounds Nonalcoholic fatty liver disease NAFLDNASH CRB-4001 is a CB1 inverse agonist which improves metabolic abnormalities and reduces inflammation and fibrosis in non-clinical models of disease. CRB-4001 is undergoing chronic pharmacokinetic studies in primates to measure brain exposure to CRB-4001. Results of these studies are expected this year and will be considered in the design of Phase 1 studies. Corbus has selected CRB-317 as an additional candidate to add to its pipeline. CRB-317 is a CB2 agonist that has significant potency and selectivity for CB2 and biological activity in animal models of inflammation and fibrosis. IND enabling pre-clinical studies and formulation work are underway. Phase 1 safety testing is expected in 2021. Financial Results for Second Quarter Ended June 30, 2020:For the quarter ended June 30, 2020, the Company reported a net loss of approximately 38.1 million or a net loss per diluted share of 0.52, compared to net income of approximately 2.2 million or net income per diluted share of 0.03, for the quarter ended June 30, 2019.For the quarter ended June 30, 2020 revenue decreased by approximately 28.8 million to 0.3 million, due primarily to revenue for the quarter ended June 30, 2019 including 27 million from the up-front licensing payment received from Kaken Pharmaceuticals in March 2019.Operating expenses for the quarter ended June 30, 2020 increased by approximately 11.0 million to 38.4 million. The increase was attributable to clinical studies costs, the costs to manufacture and supply lenabasum for clinical trials, staffing costs, commercialization costs and non-cash stock compensation expense.On July 29, 2020, Corbus announced that it received an aggregate of 71 million in gross proceeds from its at-the-market ATM offering coupled with the execution of a 50 million debt financing facility with K2 HealthVentures. Pursuant to the previously disclosed 75 million ATM facility, Corbus sold 9,167,080 shares at a weighted average price of 7.70 per share. Corbus has received the first 20 million tranche from the debt financing facility and has the option to draw 20 million from the second tranche and 10 million from the third tranche, in each case upon achievement of certain regulatory and developmental milestones.Corbus expects its cash and cash equivalents on hand of approximately 101 million at July 28, 2020 to fund operations into the third quarter of 2021. Conference Call and Webcast Information:Corbus management will host a conference call and webcast presentation for investors, analysts and other interested parties today, Thursday, August 6, 2020 at 8:30 a.m. ET.To 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, and will be archived for 90 days.About Corbus Corbus 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 rationally designed, endocannabinoid system-targeting drug candidates. The Companys lead product candidate, lenabasum, is a novel, oral, selective cannabinoid receptor type 2 CB2 agonist rationally designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis and systemic lupus erythematosus.Corbus is also developing a pipeline of drug candidates targeting the endocannabinoid system. 