Corbus Pharmaceuticals Holdings, Inc. Q2 FY2020 earnings call

Yuval Cohen noted the busy second quarter with upcoming top-line data from Phase 3 systemic sclerosis and Phase 2b cystic fibrosis studies, recent capital raise of up to $121 million, and introduction of new Board Member Dr. George Golumbeski. Barbara White discussed COVID-19 impact on clinical programs, delays in database lock, ongoing clinical studies (RESOLVE 1, CF002, DETERMINE) with updates, and preclinical programs like CRB-4001 and CRB-317. Craig Millian highlighted prelaunch activities, building launch team, field medical go-to-market model, and disease education campaign for systemic sclerosis.

No detailed breakdown of product segments with revenue contributions provided in the transcript.

Anticipates top-line data from Phase 3 systemic sclerosis study and CF Phase 2b study soon. Plans for NDA submission and commercialization post-FDA approval. Strong financial position with $101 million cash on hand provides strategic flexibility heading into data.

COVID-19 impacted clinical trials by slowing database lock, limiting in-person access to study sites, and restricting study site staff, which affected data entry and cleaning for systemic sclerosis and cystic fibrosis studies.

Q: Brian Abrahams asked about patient reported outcomes, NDA filing timelines, and COVID-19 impact on data collection.

A: Barbara White responded on KOL and regulatory views on CRISS, NDA filing timelines including pre-NDA meeting anticipation, and handling of missing data in studies due to COVID-19.

Q: Maury Raycroft inquired about SSc guidance, commercial setting, and site overlap between SSc and dermatomyositis studies.

A: Barbara White and Craig Millian discussed SSc guidance, commercial setting relevance, and site overlap in studies.

Q: Leland Gershell asked about regulatory approach for dual NDAs and timeline for CF data.

A: Barbara White explained expectation of submitting one NDA if both studies are positive and manageable timeline for CF data.

Q: Dae Gon Ha questioned data presentation for RESOLVE 1 and CF, and insights from SSc data to DM data.

A: Barbara White discussed data presentation for studies and similarities between SSc and DM data components.

Q: Elemer Piros asked about open label extension in CF trial and handling missing data in trials.

A: Barbara White responded on open label extension in CF and methods for handling missing data in studies