On March 13, 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 the fourth quarter and full year 2019 and provided a business update (Press release, Eiger Biopharmaceuticals, MAR 13, 2020, View Source [SID1234555557]).
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"We are pleased to announce the submission of the MAA for lonafarnib in Progeria and Progeroid Laminopathies and look forward to completing the NDA submission by end of the month as planned," said David Cory, President and CEO of Eiger. "Site activations, enrollment, and dosing are ongoing in our global Phase 3 HDV study, D-LIVR, and we expect to complete enrollment in 2020. We are closely monitoring the potential impact of COVID-19 on the timing and conduct of D-LIVR. We will remain responsive to any developments and take necessary steps to protect our patients and the integrity of the study."
Recent Highlights and Upcoming Milestones
Lonafarnib in Hepatitis Delta Virus (HDV)
Enrollment of Phase 3 D-LIVR study (N=400) planned to complete in 2020
Lonafarnib in Progeria and Progeroid Laminopathies
Marketing Authorization Application (MAA) to EMA completed
Accelerated Assessment for MAA granted by EMA
New Drug Application (NDA) to FDA on-track for completion by end of March 2020
Peginterferon Lambda (lambda) in HDV
Positive End of Phase 2 meeting with FDA with agreement on single Phase 3 study
Plan to finalize Scientific Advice with EMA
End-of-Treatment data from LIFT (lambda combo with lonafarnib) at EASL 2020
Corporate
Appointed Eldon Mayer as Executive Vice President and Chief Commercial Officer
Fourth Quarter and Full Year 2019 Financial Results
Cash, cash equivalents, and short-term investments as of December 31, 2019 totaled $95.0 million compared to $100.4 million at December 31, 2018, a decrease of $5.4 million.
The Company reported net losses of $16.9 million, or $0.69 per share, and $70.3 million, or $3.08 per share, for the fourth quarter and full year 2019, respectively, as compared to $16.5 million, or $0.93 per share, and $52.4 million, or $3.84 per share, for the same periods in 2018.
Research and Development expenses were $11.9 million and $51.8 million for the fourth quarter and full year 2019, respectively, as compared to $12.0 million and $37.1 million for the same periods in 2018. The increase in full year 2019 expenses was primarily due to costs associated with the Phase 3 D-LIVR HDV study, including drug supply costs, which ramped-up in 2019, employee-related costs from increased headcount and an increase in regulatory related expenses.
General and Administrative expenses were $4.6 million and $17.1 million for the fourth quarter and full year 2019, respectively, as compared to $4.1 million and $14.0 million for the same periods in 2018. The increases in fourth quarter and full year 2018 were primarily due to increases in employee-related costs, including stock-based compensation, from increased headcount and outside services for legal, consulting, advisory and accounting services.
Total operating expenses include total non-cash expenses of $1.6 million and $6.6 million for the fourth quarter and full year 2019, respectively, as compared to $1.6 million and $5.7 million for the same periods in 2018.
As of December 31, 2019, the company had 24.5 million of common shares outstanding