Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2016 Financial Results
"We believe that 2016, Eiger's first year as a publicly traded company, was a year of significant accomplishment and advancement," said
Key 2016 Milestones Achieved
Lonafarnib in HDV
- Phase 2 data across international sites from LOnafarnib With Ritonavir in HDV (LOWR HDV) program presented at the
European Association for the Study of Liver Disease (EASL) and theAmerican Association for the Study of Liver Diseases (AASLD) meetings
Pegylated Interferon Lambda in HDV
- License agreement for global rights to Lambda from
Bristol-Myers Squibb - First patient dosed in Phase 2 Lambda Interferon MonoTherapy in HDV (LIMT HDV) international study
Exendin 9-39 in Post-Bariatric Hypoglycemia (PBH)
- Phase 2 single-ascending dose study data presented at the
American Diabetes Association (ADA) - Phase 2 multiple-ascending dose (MAD) study data
- Development of novel liquid formulation for subcutaneous injection
- US orphan designation for hyperinsulinemic hypoglycemia
- EMA orphan designation for non-insulinoma pancreatogenous hypoglycemia syndrome (NIPHS) which includes PBH
Ubenimex in Pulmonary Arterial Hypertension (PAH)
- First patient dosed in Phase 2 LIBERTY North American study
- EMA orphan designation
Ubenimex in Lymphedema
- First patient dosed in Phase 2 ULTRA international study
Extended company runway through mid-2018
$20 million follow on financing in August$15 million tranche from$25 million venture debt line received from Oxford in December
Fourth Quarter and Full Year 2016 Financial Results
Net loss for the fourth quarter of 2016 was
Research and development expenses for the fourth quarter of 2016 were
Research and development expenses for the year ended
General and Administrative expenses for the fourth quarter of 2016 were
General and administrative expenses for the year ended
As of
Key Anticipated Milestones in 2017
- LOWR HDV program: end-of-study data in Q2, and agency meeting in Q4
- Lambda in HDV: US IND filing in Q2, interim data from LIMT HDV study in Q4
- Exendin 9-39 in PBH: completion of MAD study in Q2, completion of PK study with novel liquid formulation in Q3, and initiation of Phase 2 - 28-day study in Q4
- Ubenimex in PAH: complete LIBERTY enrollment in Q2; data Q1 2018
- Ubenimex in Lymphedema: complete ULTRA enrollment in Q3; data Q2 2018.
About Eiger
Eiger is a clinical-stage biopharmaceutical company committed to bringing to market novel products for the treatment of rare diseases. The company has built a diverse portfolio of well-characterized product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which an effective therapy is urgently needed. 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, included in this press release regarding our strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives, intentions, beliefs and expectations of management are forward-looking statements. These forward- looking statements may be accompanied by such words as "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "potential," "project," "target," "will" and other words and terms of similar meaning. Examples of such statements include, but are not limited to, our ability to timely and successfully achieve, all or any of the anticipated 2017 and 2018 milestones, whether or not pegylated interferon lambda or lonafarnib or ubenimex or exendin 9-39 may be further developed and approved, statements relating to the availability of cash for Eiger's future operations and drug development portfolio, Eiger's ability to develop its drug candidates for potential commercialization, the timing of the commencement and number and completion of Phase 2 trials and whether the products can be successfully developed or commercialized. 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 Annual Report on Form 10-K for the period ended
Investors:
Eiger BioPharmaceuticals Inc. |
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Selected Statements of Operations Financial Data |
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(in thousands, except per share amounts) |
|||||||||
(unaudited) |
|||||||||
Three Months Ended |
Year Ended |
||||||||
December 31, |
December 31, |
||||||||
2016 |
2015 |
2016 |
2015 |
||||||
Operating expenses: |
|||||||||
Research and development |
$ 9,377 |
$ 3,624 |
$ 33,014 |
$ 8,117 |
|||||
General and administrative |
3,532 |
3,087 |
13,106 |
4,855 |
|||||
Total operating expenses |
12,909 |
6,711 |
46,120 |
12,972 |
|||||
Loss from operations |
(12,909) |
(6,711) |
(46,120) |
(12,972) |
|||||
Interest expense, net |
(5) |
(350) |
(690) |
(350) |
|||||
Other expense, net |
146 |
- |
(277) |
- |
|||||
Net loss |
$ (12,768) |
$ (7,061) |
$ (47,087) |
$ (13,322) |
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Net loss per common share: |
|||||||||
Basic and diluted |
$ (1.53) |
$ (25.78) |
$ (7.84) |
$ (62.19) |
|||||
Shares used to compute net loss per common share: |
|||||||||
Basic and diluted |
8,356,659 |
273,860 |
6,007,027 |
214,228 |
Eiger BioPharmaceuticals Inc. |
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Selected Balance Sheets Financial Data |
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(in thousands) |
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(unaudited) |
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December 31, |
December 31, |
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2016 |
2015 |
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Balance Sheet Data: |
|||||||||
Cash, cash equivalents and investments |
$ 59,936 |
$ 4,778 |
|||||||
Working capital |
55,229 |
(2,895) |
|||||||
Total assets |
60,736 |
5,582 |
|||||||
Total stockholders' equity |
40,721 |
(5,152) |
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