Eiger BioPharmaceuticals Reports Second Quarter 2020 Financial Results and Provides Business Update
"Eiger is executing toward multiple important milestones across our pipeline, including anticipated FDA approval of Zokinvy™ in Progeria and Progeroid Laminopathies," said
Recent Highlights and Upcoming Milestones
Zokinvy™ (lonafarnib) in Progeria and Progeroid Laminopathies
- New Drug Application (NDA) accepted for filing by FDA with priority review and Prescription Drug User Fee Act (PDUFA) target action date of
November 20, 2020 - Marketing Authorization Application (MAA) under review by EMA will follow a standard review timeline. EMA request for inspections, in addition to travel restrictions due to COVID-19, will delay EMA from completing its review within the framework of previously granted accelerated assessment.
Lonafarnib in Hepatitis Delta Virus (HDV)
- Phase 3 D-LIVR study (N=400) continues to enroll and dose patients
- Full enrollment expected in 2021
Peginterferon Lambda in HDV
- Phase 2 LIFT (combo with lonafarnib) end-of-treatment data planned for EASL 2020; end-of-study data planned for AASLD 2020
- Single, Phase 3 study design agreement with FDA and EMA
Peginterferon Lambda in COVID-19
- Six International Investigator Sponsored Studies in progress
Second Quarter 2020 Financial Results
Cash, cash equivalents, and short-term investments as of
The Company reported net loss of
Research and Development expenses were
General and Administrative expenses were
Total operating expenses include total non-cash expenses of
As of
About Eiger
Eiger is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs.
Eiger's lead clinical programs target Hepatitis Delta Virus (HDV) infection, the most serious form of human viral hepatitis. Eiger is developing two complementary treatments for HDV. Lonafarnib is a first-in-class, oral prenylation inhibitor in a global Phase 3 trial. Peginterferon lambda is a first-in-class, well-tolerated type III interferon entering Phase 3.
Eiger has filed an NDA and MAA for lonafarnib for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. FDA PDUFA date is
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 anticipating significant milestones in 2020 and 2021, the timing of our ongoing and planned clinical development, including the potential for approval of our lonafarnib product candidate in the
Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" sections in the Quarterly Report on Form 10-Q for the quarter ended
Investors and Media:
(650) 619-6115
[email protected]
(650) 272-6138
[email protected]
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Condensed Consolidated Balance Sheets |
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(in thousands) |
|||||||||
Six Months Ended |
Year Ended |
||||||||
|
|
||||||||
2020 |
2019(1) |
||||||||
(unaudited) |
|||||||||
ASSETS |
|||||||||
Cash and cash equivalents |
$ 62,813 |
$ 39,373 |
|||||||
Debt securities, available-for-sale |
27,962 |
55,621 |
|||||||
Prepaid expenses and other current assets |
6,564 |
5,390 |
|||||||
Total current assets |
97,339 |
100,384 |
|||||||
Property and equipment, net |
616 |
590 |
|||||||
Operating lease right-of-use assets |
1,421 |
1,654 |
|||||||
Other assets |
3,781 |
2,511 |
|||||||
Total assets |
$ 103,157 |
$ 105,139 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
$ 16,147 |
$ 16,949 |
|||||||
Other liabilities |
28,519 |
31,710 |
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Stockholders' equity |
58,491 |
56,480 |
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Total liabilities and stockholders' equity |
$ 103,157 |
$ 105,139 |
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(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended |
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Condensed Consolidated Statements of Operations Financial Data |
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(in thousands, except per share and share amounts) |
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Three Months Ended |
Six Months Ended |
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|
|
|||||||||
(unaudited) |
(unaudited) |
|||||||||
2020 |
2019 |
2020 |
2019 |
|||||||
Operating expenses: |
||||||||||
Research and development(1) |
$ 9,754 |
$ 12,936 |
$ 19,235 |
$ 25,804 |
||||||
General and administrative(1) |
4,873 |
4,225 |
10,114 |
8,282 |
||||||
Total operating expenses |
14,627 |
17,161 |
29,349 |
34,086 |
||||||
Loss from operations |
(14,627) |
(17,161) |
(29,349) |
(34,086) |
||||||
Interest expense |
(891) |
(869) |
(1,775) |
(1,634) |
||||||
Interest income |
186 |
502 |
553 |
1,013 |
||||||
Other income (expense), net |
6 |
1 |
6 |
(9) |
||||||
Net loss |
$ (15,326) |
$ (17,527) |
$ (30,565) |
$ (34,716) |
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Net loss per common share: |
||||||||||
Basic and diluted |
$ (0.60) |
$ (0.75) |
$ (1.22) |
$ (1.63) |
||||||
Shares used to compute net loss per common share: |
||||||||||
Basic and diluted |
25,501,514 |
23,408,652 |
25,001,432 |
21,338,551 |
||||||
(1) |
Includes stock-based compensation expense of: |
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Three Months Ended |
Six Months Ended |
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|
|
|||||||||
2020 |
2019 |
2020 |
2019 |
|||||||
Research and development |
$ 398 |
$ 442 |
$ 787 |
$ 807 |
||||||
General and administrative |
1,064 |
1,045 |
2,304 |
1,875 |
||||||
Total stock-based compensation expense |
$ 1,462 |
$ 1,487 |
$ 3,091 |
$ 2,682 |
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