Corbus Pharmaceuticals Holdings, Inc. Q1 FY2020 earnings call

Clinical Trials

• RESOLVE 1 Phase 3 study in systemic sclerosis on track for topline data in summer 2020; Phase 2b lenabasum study in cystic fibrosis to follow with topline data later.
• CRB-4001 Phase 1 study to start later in 2020; selection of next candidate also scheduled for later 2020.

COVID-19 Impact

• Minimal impact on delivery of topline data from ongoing Phase 3 and Phase 2 studies; remote working implemented, including virtual meetings with study sites and remote/data monitoring procedures in line with FDA recommendations.

Enrollment

• 99% of Phase 3 systemic sclerosis study subjects and 96% of Phase 2b cystic fibrosis study subjects completed double-blind randomized placebo-controlled dosing; Phase 3 DETERMINE study in dermatomyositis ~80% enrolled.

Commercial Program

• Building commercial capabilities; market research completed, including awareness/perception survey of rheumatologists treating systemic sclerosis; disease education campaign (totalssc.com) launched in March with encouraging engagement.

Pipeline

• CRB-4001 Phase 1 study on track to start in third quarter 2020; internal research team working on expanding pipeline, anticipating selection of first organically developed CB2 agonist candidate within months.

No distinct product segments with financial performance breakdown reported.

Financial

• Ended Q1 with $46.6 million in cash and cash equivalents; cash on hand and remaining $7.5 million in milestone payments from Cystic Fibrosis Foundation Award to fund operations into Q4 2020.

Data Readouts

• Anticipate multiple data readouts in coming months, including topline results from RESOLVE 1 Phase 3 study in systemic sclerosis in summer 2020 and Phase 2b lenabasum study in cystic fibrosis later.

COVID-19 Impact

• Potential minor delays in data collection due to travel restrictions and remote working, but remote data monitoring and central data monitoring procedures in place to manage; expected to have minimal impact on study powering.

Q: Bert Kinsey asked about data collection in RESOLVE 1 study and impact of COVID-19 on data imputation and study power.

A: Barbara White responded that 99% of subjects finished dosing, with 28-day safety follow-up remaining; data entry is over 98% complete, remote data monitoring implemented, and powering remains adequate with statistical analysis for data imputation.

Q: Maury Raycroft asked about endpoints in SSc study, totalSSC website.

A: Barbara White discussed endpoints and Yuval Cohen explained the totalSSC website is for rheumatologists treating systemic sclerosis, not patients, focusing on disease education.

Q: Leland Gershell asked about OLE enrollment and FDA interaction on endpoints.

A: Barbara White clarified OLE eligibility includes patients who completed dosing with possible extensions due to COVID-19, and FDA will assess totality of data.

Q: Christopher Marai asked about OLE eligibility and timing of SSc vs CF data.

A: Barbara White explained OLE eligibility details and that CF data top line will be released approximately a month after SSc data, with top line results including efficacy and safety information.