On May 7, 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 first quarter 2020 and provided a business update (Press release, Eiger Biopharmaceuticals, MAY 7, 2020, View Source [SID1234557393]).
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"We achieved key milestones this quarter across programs, including Eiger’s first NDA and MAA submissions. Lonafarnib would be the first approved treatment for patients with Progeria and Progeroid Laminopathies," said David Cory, President and CEO of Eiger. "As previously announced, due to the impact of COVID-19, we anticipate full enrollment of our global Phase 3 HDV D-LIVR study in 2021, and we continue to enroll and dose patients. Peginterferon lambda in HDV is now Phase 3-ready, after harmonizing a single pivotal study with FDA and EMA. In addition, we look forward to future results from ongoing investigator sponsored studies of peginterferon lambda in COVID-19 patients."
Recent Highlights and Upcoming Milestones
Lonafarnib in Progeria and Progeroid Laminopathies
Marketing Authorization Application (MAA) validated by EMA
Accelerated Assessment for MAA granted by EMA
New Drug Application (NDA) submitted to FDA in March 2020
Lonafarnib in Hepatitis Delta Virus (HDV)
Phase 3 D-LIVR study (N=400) continues to enroll and dose patients
Full enrollment expected in 2021 due to previously announced impact of COVID-19
Prioritizing the safety of D-LIVR patients, study continuity, and study integrity
Peginterferon Lambda in HDV
Single pivotal Phase 3 study harmonized with FDA and EMA
Phase 2 LIFT (combo with lonafarnib) end-of-treatment data planned for EASL 2020
Peginterferon Lambda in COVID-19
First patients dosed at Stanford University
Six International Investigator Sponsored Studies initiating and enrolling
First Quarter 2020 Financial Results
Cash, cash equivalents, and short-term investments as of March 31, 2020 totaled $77.6 million compared to $95.0 million at December 31, 2019, a decrease of $17 million.
The Company reported net loss of $15.2 million, or $0.62 per share, for first quarter 2020, as compared to $17.2 million, or $0.90 per share, for first quarter 2019.
Research and Development expenses were $9.5 million for first quarter 2020, as compared to $12.9 million for first quarter 2019. The decrease was primarily due to lower clinical trial related expenses, including clinical material costs.
General and Administrative expenses were $5.2 million for first quarter 2020, as compared to $4.1 million for first quarter 2019. The increase was primarily due to increases in employee-related costs, including stock-based compensation, from increased headcount.
Total operating expenses include total non-cash expenses of $2.0 million for first quarter 2020, as compared to $1.4 million for the same period in 2019. As of March 31, 2020 the Company had 24.6 million of common shares outstanding.