Eiger BioPharmaceuticals Reports First Quarter 2018 Financial Results
"The Eiger HDV program is moving into Phase 3 with a single, international, multi-center registration trial of approximately 300 HDV infected patients called D-LIVR (Delta Liver Improvement and Virologic Response in HDV)," said
Key Achievements
Hepatitis D Virus (HDV) Program
Lonafarnib in HDV
- Positive face-to-face
FDA meeting held onFebruary 14, 2018 - Agreement with the
FDA on a single pivotal Phase 3 study for approval - Sub-Analysis of Phase 2 data reveals high response rates from an All-Oral regimen of lonafarnib and ritonavir in HDV infected patients (2018 EASL)
Lambda in HDV
- Phase 2 LIFT (Lambda InterFeron combo Therapy) study initiated at NIH
Exendin 9-39 in PBH
- Phase 2 PREVENT (28-day) study initiated across multiple U.S. sites
Ubenimex in Lymphedema
- Phase 2 ULTRA study enrolled (N=54) and dosing
Corporate Activity
Eldon Mayer III , pharma industry veteran, appointed to the BoardDavid Apelian joined Eiger as COO and Executive Medical Officer
Anticipated 2018 Milestones
- Lonafarnib in HDV: Phase 3 program initiation
- Lambda in HDV: Phase 2 LIMT study dosing completion
- Exendin 9-39 in PBH: Phase 2 PREVENT study completion
- Ubenimex in Lymphedema: Phase 2 ULTRA study completion
First Quarter 2018 Financial Results
Net loss for the first quarter of 2018 was
Research and development expenses for the first quarter of 2018 were
General and administrative expenses for the first quarter of 2018 were
As of
About Eiger
Eiger is a clinical-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for rare diseases. We are committed to translational innovation and the development of well-characterized drugs acting on newly identified or novel targets. Our mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients with rare diseases. Our lead program in Hepatitis Delta Virus (HDV) infection, is moving into Phase 3 with a single, pivotal trial planned to initiate by the end of the year. For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.
Note Regarding Forward-Looking Statements
This press release contains "forward-looking" statements that involve substantial risks and uncertainties.All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, business strategy and plans and objectives for future operations, are forward looking statements. These forward-looking statements include terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms. Forward looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned clinical development, including whether the D-LIVR study will be supported by the
Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended
Investors:
Three Months Ended |
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March 31, |
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2018 |
2017 |
||||||
Operating expenses: |
|||||||
Research and development |
$ 5,512 |
$ 7,464 |
|||||
General and administrative |
2,994 |
3,522 |
|||||
Total operating expenses |
8,506 |
10,986 |
|||||
Loss from operations |
(8,506) |
(10,986) |
|||||
Interest expense |
(398) |
(363) |
|||||
Interest income |
94 |
110 |
|||||
Other expense, net |
(21) |
- |
|||||
Net loss |
$ (8,831) |
$ (11,239) |
|||||
Net loss per common share: |
|||||||
Basic and diluted |
$ (0.84) |
$ (1.34) |
|||||
Shares used to compute net loss per common share: |
|||||||
Basic and diluted |
10,529,350 |
8,360,539 |
|||||
Eiger BioPharmaceuticals Inc. |
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Selected Balance Sheets Financial Data |
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(in thousands) |
|||||||
(unaudited) |
|||||||
March 31, |
December 31, |
||||||
2018 |
2017 |
||||||
Balance Sheet Data: |
|||||||
Cash, cash equivalents and investments |
$ 33,247 |
$ 41,779 |
|||||
Working capital |
26,362 |
35,222 |
|||||
Total assets |
34,221 |
42,882 |
|||||
Total stockholders' equity |
14,731 |
22,522 |
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