Earnings release
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Exhibit 99.1 • • • CERECOR Cerecor Reports First Quarter 2021 Financial Results and Provides Business Updates Announced CERC - 002 received Fast Track Designation from the U.S. Food and Drug Administration , following positive Phase 2 clinical trial for the treatment of patients hospitalized with COVID - 19 ARDS Secured exclusive , world - wide rights to develop , manufacture and commercialize CERC - 002 for all indications Poised to deliver significant number of clinical and regulatory catalysts in 2021 ROCKVILLE , Md . and CHESTERBROOK , Pa . , May 13 , 2021 Cerecor Inc. ( NASDAQ : CERC ) , a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for rare and orphan diseases , today announced recent business progress and first quarter 2021 financial results . " It has been a productive start to the year , " said Mike Cola , Chief Executive Officer of Cerecor . " Over the course of 2021 , we anticipate multiple data readouts , including CERC - 007 in multiple myeloma and adult onset Still's disease and CERC - 006 in complex lymphatic malformations , that will demonstrate significant progress in developing treatments for immunology , oncology , and rare genetic disorders . " Business Updates : • • Cerecor announced an expanded agreement with Kyowa Kirin for the world - wide rights to develop , manufacture and commercialize the anti - LIGHT antibody CERC - 002 for all indications , including severe pediatric onset inflammatory bowel disease and acute respiratory distress syndrome ( ARDS ) including COVID - 19 ARDS . Kyowa Kirin has an option to retain the rights in Japan . The U.S. Food and Drug Administration ( FDA ) granted Fast Track designation to CERC - 002 for the treatment of hospitalized COVID - 19 patients . Cerecor announced that it has dosed its first patient in a Phase 1b proof - of - concept , multi - center , open- label dose - escalation , clinical trial of CERC - 007 , a fully human anti - IL - 18 monoclonal antibody , in patients with adult onset Still's disease ( AOSD ) . Program Updates : • CERC - 002 : Anti - LIGHT monoclonal antibody in clinical development for COVID - 19 ARDS and severe pediatric onset Crohn's disease . ° ° Completed double - blinded , placebo - controlled Phase 2 proof - of - concept study of CERC - 002 in hospitalized COVID - 19 patients with mild - to - moderate ARDS . Final analysis inclusive of the 60 - day safety update in the randomized placebo - controlled study demonstrated a single dose of CERC - 002 led to a statistically significant reduction in respiratory failure and mortality at Day 28 in patients hospitalized with COVID - 19 - associated pneumonia and mild to moderate ARDS , the primary endpoint , ( n = 62 , p = 0.044 ) . At both the 28 - day and the 60 - day final timepoints , an approximately 50 % trend in mortality reduction ( 22.5 % vs 10.8 % ) was observed . CERC - 002 was safe and well - tolerated on top of standard of care including high dose steroids ( > 90 % ) and remdesivir ( > 65 % ) . CERC - 002 was granted FDA Fast Track designation for the treatment of hospitalized patients with COVID - 19 .