On November 8, 2019 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 three and nine months ended September 30, 2019 and provided a business update (Press release, Eiger Biopharmaceuticals, NOV 8, 2019, View Source [SID1234550784]).
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"We are advancing four Breakthrough Therapy Designation programs into late stages, all with first-in-class therapies targeting rare diseases with no approved treatments," said David Cory, Eiger President and CEO. "We recently completed successful pre-NDA and pre-MAA meetings with both FDA and EMA for Progeria and Progeroid Laminopathies and plan to submit an NDA by year-end. We recently announced positive results from the HDV Lambda and Lonafarnib combination LIFT study, which will be presented as an oral late-breaker at AASLD. Our Phase 3 HDV global D-LIVR study continues to activate sites, enroll and dose patients. We look forward to updating on continued progress in the future."
Recent Highlights
Lonafarnib in Progeria and Progeroid Laminopathies
Positive pre-NDA meeting with FDA
Positive pre-MAA meeting with EMA
Peginterferon Lambda (Lambda) in Hepatitis Delta Virus (HDV)
Late-breaking oral presentation of positive Phase 2 LIFT (lambda + lonafarnib boosted with ritonavir) interim end-of-treatment results accepted for AASLD
95% of patients achieved primary endpoint of >2 log reduction in HDV RNA
>50% of patients were HDV RNA undetectable or BLOQ
Adverse events were mostly mild to moderate
Breakthrough Therapy Designation granted by FDA
Avexitide in Post-Bariatric Hypoglycemia (PBH)
Positive End of Phase 2 meeting with FDA for avexitide in PBH
Upcoming Milestones
Oral presentation of Phase 2 LIFT interim end-of-treatment results in HDV at AASLD
NDA submission for Progeria and Progeroid Laminopathies by year-end, followed by MAA submission in the first quarter of 2020
Phase 3 D-LIVR study in HDV (N=400) enrollment update after year-end
End of Phase 2 meeting for Lambda monotherapy in HDV in the first quarter of 2020
Third Quarter 2019 Financial Results
Cash, cash equivalents, and short-term investments as of September 30, 2019 totaled $109.9 million compared to $125.3 million at June 30, 2019, a decrease of $15.4 million.
The Company reported a net loss of $18.6 million, or $0.76 per share for third quarter 2019, as compared to $17.1 million, or $1.20 per share, for the same period in 2018.
Research and Development expenses were $14.1 million for third quarter 2019, as compared to $13.2 million for the same period in 2018, an increase of $0.9 million. The increase was primarily due to employee-related costs, including stock-based compensation, and expenditures related to our clinical programs.
General and Administrative expenses were $4.2 million for third quarter 2019, as compared to $3.6 million for the same period in 2018, an increase of $0.6 million. The increase was primarily due to additional employee-related costs, including stock-based compensation.
Third quarter 2019 operating expenses include total non-cash expenses of $1.8 million, as compared to $1.5 million for the same period in 2018.
As of September 30, 2019, Eiger had 24.5 million of common shares outstanding.