On August 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 second quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, AUG 6, 2020, View Source [SID1234563203]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Eiger is executing toward multiple important milestones across our pipeline, including anticipated FDA approval of Zokinvy in Progeria and Progeroid Laminopathies," said David Cory, President and CEO. "Our Phase 3 HDV D-LIVR trial continues to enroll and dose patients with full enrollment expected in 2021, and we plan for end-of-treatment and end-of-study data from our Phase 2 HDV LIFT study of peginterferon lambda in combination with lonafarnib this year. In addition, we look forward to results from multiple ongoing investigator sponsored studies of peginterferon lambda in COVID-19 patients."
Recent Highlights and Upcoming Milestones
Zokinvy (lonafarnib) in Progeria and Progeroid Laminopathies
New Drug Application (NDA) accepted for filing by FDA with priority review and Prescription Drug User Fee Act (PDUFA) target action date of November 20, 2020
Marketing Authorization Application (MAA) under review by EMA will follow a standard review timeline. EMA request for inspections, in addition to travel restrictions due to COVID-19, will delay EMA from completing its review within the framework of previously granted accelerated assessment.
Lonafarnib in Hepatitis Delta Virus (HDV)
Phase 3 D-LIVR study (N=400) continues to enroll and dose patients
Full enrollment expected in 2021
Peginterferon Lambda in HDV
Phase 2 LIFT (combo with lonafarnib) end-of-treatment data planned for EASL 2020; end-of-study data planned for AASLD 2020
Single, Phase 3 study design agreement with FDA and EMA
Peginterferon Lambda in COVID-19
Six International Investigator Sponsored Studies in progress
Second Quarter 2020 Financial Results
Cash, cash equivalents, and short-term investments as of June 30, 2020 totaled $90.8 million.
The Company reported net loss of $15.3 million, or $0.60 per share, for second quarter 2020, as compared to $17.5 million, or $0.75 per share, for second quarter 2019.
Research and Development expenses were $9.8 million for second quarter 2020, as compared to $12.9 million for second quarter 2019. The decrease was primarily due to a decrease in regulatory expenses and lower clinical trial related expenses, including clinical material costs.
General and Administrative expenses were $4.9 million for second quarter 2020, as compared to $4.2 million for second quarter 2019. The increase was primarily due to an increase in outside legal, consulting, advisory and accounting services.
Total operating expenses include total non-cash expenses of $1.8 million for second quarter 2020, as compared to $1.8 million for the same period in 2019.
As of June 30, 2020, the Company had 27,241,640 of common shares outstanding.