Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update
"We expect 2019 to be a transformative year for Eiger as we plan to file the first-ever NDA and MAA for Progeria and Progeroid Laminopathies and to enroll the first-ever international Phase 3 study in Hepatitis Delta Virus infection," said
Recent Highlights
Hepatitis D Virus (HDV) Program
Lonafarnib in HDV
- Lonafarnib+Ritonavir patent portfolio expanded to include US,
Europe andJapan - Breakthrough Therapy designation granted by
FDA - PRIME designation granted by EMA
- First site initiated in Phase 3 D-LIVR study
Lambda in HDV
- Phase 2 LIMT (mono therapy) end of study results selected as a late-breaker oral presentation at The International Liver Congress™ 2019
- Phase 2 LIFT (combo therapy with lonafarnib) dosing at NIH (N=26)
Lonafarnib in Progeria and Progeroid Laminopathies Program
- Breakthrough Therapy designation granted by
FDA
Avexitide in Post-Bariatric Hypoglycemia (PBH) Program
- Positive Phase 2 PREVENT 28-day study data (N=18)
Corporate Activity
Sri Ryali , MBA, appointed Eiger Chief Financial OfficerStephana Patton , PhD, JD, pharma industry veteran, appointed Eiger as General Counsel, Corporate Secretary and Chief Compliance OfficerChristine Murray , MS, RAC, industry veteran and Senior Vice President of Global Regulatory Affairs atUltragenyx Pharmaceutical, Inc. , appointed to Board- R&D Day held on
December 11, 2018 in NYC - October underwritten public offering raised
$47.7 million in net proceeds
Anticipated 2019 Milestones
- Phase 3 D-LIVR study (N=400) complete enrollment in HDV planned by year-end
- Phase 2 LIMT end-of-study study results in HDV oral presentation at EASL
- Phase 2 LIFT end-of-treatment study results in HDV planned at AASLD
- NDA and MAA filings in Progeria and Progeroid Laminopathies planned
- Phase 2 PREVENT end-of-study results in PBH oral presentation at
ENDO - End of Phase 2 meeting for avexitide in PBH with regulators planned
Fourth Quarter and Full Year 2018 Financial Results
Cash, cash equivalents, and short-term investments as of
The Company reported net losses of
Research and Development expenses were
General and Administrative expenses were
Total operating expenses include total non-cash expenses of
In October, 2018, Eiger announced the closing of its underwritten public offering of 4,830,918 shares of its common stock at a price to the public of
As of
About Eiger
Eiger is a late stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases. We innovate by developing well-characterized drugs in newly identified or novel targets in rare diseases. Our mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients.
The company's lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. Eiger is also preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in 2019. 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 plans to complete enrollment of our D-LIVR study by the end of 2019, submit an NDA and MAA for Progeria and progeroid laminopathies in 2019, timing of end of treatment data in our LIFT study and progress our Phase 3 study in HDV; our ability to transition into a commercial stage biopharmaceutical company; our ability to finance the continued advancement of our development pipeline products; and the potential for success of any of our product candidates.
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 year ended
Investors:
Email: [email protected]
Phone: 1-650-619-6115
Email: [email protected]
Phone: 1-650-272-6138
Eiger BioPharmaceuticals Inc. |
||||||||||||
Condensed Consolidated Balance Sheets |
||||||||||||
(in thousands) |
||||||||||||
Year Ended |
||||||||||||
December 31, |
||||||||||||
2018(1) |
2017(1) |
|||||||||||
ASSETS |
||||||||||||
Cash and cash equivalents |
$ 61,262 |
$ 32,035 |
||||||||||
Debt securities, available-for-sale |
39,091 |
9,744 |
||||||||||
Prepaid expenses and other current assets |
1,492 |
712 |
||||||||||
Total current assets |
101,845 |
42,491 |
||||||||||
Property and equipment, net |
167 |
79 |
||||||||||
Other assets |
436 |
312 |
||||||||||
Total assets |
$ 102,448 |
$ 42,882 |
||||||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
||||||||||||
Current liabilities |
$ 10,024 |
$ 7,269 |
||||||||||
Other liabilities |
25,832 |
13,091 |
||||||||||
Stockholders' equity |
66,592 |
22,522 |
||||||||||
Total liabilities and stockholders' equity |
$ 102,448 |
$ 42,882 |
||||||||||
(1)Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the years ended December 31, 2018 and 2017. |
Eiger BioPharmaceuticals Inc. |
|||||||||||||
Condensed Consolidated Statements of Operations Financial Data |
|||||||||||||
(in thousands, except per share and share amounts) |
|||||||||||||
Three Months Ended |
Year Ended |
||||||||||||
December 31, |
December 31, |
||||||||||||
(unaudited) |
|||||||||||||
2018 |
2017 |
2018 |
2017 |
||||||||||
Operating expenses: |
|||||||||||||
Research and development(1) |
$ 12,011 |
$ 7,779 |
$ 37,091 |
$ 29,519 |
|||||||||
General and administrative(1) |
4,082 |
2,806 |
13,956 |
12,001 |
|||||||||
Total operating expenses |
16,093 |
10,585 |
51,047 |
41,520 |
|||||||||
Loss from operations |
(16,093) |
(10,585) |
(51,047) |
(41,520) |
|||||||||
Interest expense |
(755) |
(395) |
(2,329) |
(1,524) |
|||||||||
Interest income |
343 |
89 |
997 |
410 |
|||||||||
Other (expense) income, net |
4 |
(2) |
(12) |
186 |
|||||||||
Net loss |
$ (16,501) |
$ (10,893) |
$ (52,391) |
$ (42,448) |
|||||||||
Net loss per common share: |
|||||||||||||
Basic and diluted |
$ (0.92) |
$ (1.11) |
$ (3.82) |
$ (4.86) |
|||||||||
Shares used to compute net loss per common share: |
|||||||||||||
Basic and diluted |
17,926,315 |
9,799,328 |
13,711,034 |
8,727,935 |
|||||||||
(1) |
Includes stock-based compensation expense of: |
||||||||||||
Three Months Ended |
Year Ended |
||||||||||||
December 31, |
December 31, |
||||||||||||
2018 |
2017 |
2018 |
2017 |
||||||||||
Research and development |
$ 362 |
$ 443 |
$ 1,500 |
$ 1,214 |
|||||||||
General and administrative |
1,149 |
577 |
3,507 |
3,029 |
|||||||||
Total stock-based compensation expense |
$ 1,511 |
$ 1,020 |
$ 5,007 |
$ 4,243 |
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