On November 6, 2020 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, reported financial results for third quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 6, 2020, View Source [SID1234570223]).
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Recent Highlights and Upcoming Milestones
ZokinvyTM (lonafarnib) in Progeria and Progeroid Laminopathies
New Drug Application (NDA) Prescription Drug User Fee Act (PDUFA) target action date November 20, 2020
Lonafarnib in Hepatitis Delta Virus (HDV)
Phase 3 D-LIVR study full enrollment expected in 2021
Peginterferon Lambda (Lambda) in HDV
Phase 2 LIFT (combo with lonafarnib) end-of-study data expected at AASLD 2020
Agreement with FDA and EMA on single, Phase 3 Lambda monotherapy study design
Peginterferon Lambda (Lambda) in COVID-19
Toronto General Hospital, University Health Network (N=60)
Mean baseline viral load: 6.7 log copies/mL
79% (Lambda) vs 38% (placebo) (p=0.013) clear virus by Day 7
> 6 log copies/mL correlates with the threshold for infectivity
Stanford University School of Medicine (N=120)
Mean baseline viral load: < 4 log copies/mL
Median time to cessation of viral shedding was 7 days in both groups
Results of both studies support Lambda activity in high baseline viral load patients
Lambda was well tolerated in both studies with few adverse events, which included minimal elevations of transaminases which self-resolved
Plan to meet with FDA to discuss data and next steps
Third Quarter 2020 Financial Results
Cash, cash equivalents, and short-term investments as of September 30, 2020 totaled $125.3 million.
The Company reported net loss of $15.7 million, or $0.52 per share, for third quarter 2020, as compared to $18.6 million, or $0.76 per share, for third quarter 2019.
Research and Development expenses were $9.8 million for third quarter 2020, as compared to $14.1 million for third quarter 2019. The decrease was primarily due to a decrease in clinical trial related expenses, including clinical trial material costs.
General and Administrative expenses were $5.0 million for third quarter 2020, as compared to $4.2 million for third quarter 2019. The increase was primarily due to an increase in outside consulting, advisory and accounting services and an increase in personnel-related expenses.
Total operating expenses include total non-cash expenses of $1.9 million for third quarter 2020, as compared to $1.8 million for the same period in 2019.
As of September 30, 2020, the Company had 31.9 million of common shares outstanding.