Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of targeted therapies for rare diseases, announced today financial results for the three months and year ended December 31, 2017 and provided a business update.
"We met with the FDA in February to discuss development plans for our lead program in HDV. The meeting was very positive and the Agency agreed that our HDV program can advance forward into Phase 3 development with a single, registration trial. We expect to receive written minutes from the Agency shortly and plan to communicate further details on our development plans during the second quarter of 2018," said David Cory, President and CEO. "In addition, we expect to report Phase 2 results from all three pipeline programs in the second half of 2018."
Key Achievements
Hepatitis D Virus (HDV) Program
Lonafarnib in HDV
Positive Phase 2 LOWR HDV (LOnafarnib With Ritonavir in HDV) Program presentations at The International Liver Congress™ (EASL 2017)
Positive face to face FDA meeting held on February 14, 2018
Lambda in HDV
Positive Phase 2 interim data from LIMT HDV (Lambda Interferon Monotherapy Trial inHDV) reported at American Association for the Study of Liver Diseases (AASLD 2017) meeting
Orphan Drug Designation granted by FDA
Fast Track Designation granted by FDA
Exendin 9-39 in PBH
Positive Phase 2 MAD data at American Diabetes Association (ADA 2017) meeting
Phase 1 PK study successfully completed with novel liquid formulation
Phase 2 PREVENT (28-day) study initiation
Ubenimex in Lymphedema
Phase 2 ULTRA study enrollment completed; N=54
Corporate Activity
David Apelian, MD, PhD, MBA, pharma industry veteran, appointed to Board
Evan Loh, MD, pharma industry veteran, appointed to Board
Financing completed in October 2017 raising $19.8 million in net proceeds
Eldon Mayer III, pharma industry veteran, appointed to Board
David Apelian joined Eiger as COO and Executive Medical Officer
Anticipated 2018 Milestones
Lonafarnib in HDV: Initiation of Phase 3 Program
Lambda in HDV: Dosing completion in LIMT study
Exendin 9-39 in PBH: Phase 2 PREVENT study completion
Ubenimex in Lymphedema: Phase 2 ULTRA study completion
Fourth Quarter and Full Year 2017 Financial Results
Net loss for the fourth quarter of 2017 was $10.9 million, or $1.11 per share basic and diluted, compared to a net loss of $12.8 million, or $1.53 per share basic and diluted for the fourth quarter of 2016. Net losses were $42.4 million and $47.1 million for the years ended December 31, 2017 and 2016, respectively, or $4.86 and $7.84 per share basic and diluted, respectively.
Research and development expenses for the fourth quarter of 2017 were $7.8 million compared to $9.4 million for the fourth quarter of 2016, a decrease of $1.6 million. The decrease was primarily due to a $0.9 million reduction in clinical and drug supply expenditures and a $0.8 million reduction headcount related costs. R&D expenses were $29.5 million and $33.0 million for the years ended December 31, 2017 and December 31, 2016, respectively.
General and administrative expenses for the fourth quarter of 2017 were $2.8 million compared to $3.5 million for the fourth quarter of 2016, a decrease of $0.7 million. The decrease was primarily due a $0.4 million decrease in stock-based compensation expense. G&A expenses for the years ended December 31, 2017 and December 31, 2016 were $12.0 million and $13.1 million, respectively.
As of December 31, 2017, Eiger had cash, cash equivalents and short-term marketable securities of $41.8 million, compared to $59.9 million at December 31, 2016. On October 31, 2017, Eiger announced the closing of its underwritten public offering of 2,132,961 shares of its common stock that included the exercise in full of the underwriter's option to purchase up to 278,212 shares, at a price of $10.00 per share. The offering was made under Eiger's effective shelf registration statement and resulted in net proceeds to the company of approximately $19.8 million, after deducting underwriting discounts and commissions and estimated...
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