Eiger BioPharmaceuticals Reports Second Quarter 2019 Financial Results and Provides Business Update
"Eiger is advancing a late stage pipeline with three breakthrough therapy designations towards key milestones in 2019, including submission of the first ever NDA and MAA for Progeria and Progeroid Laminopathies," said
Recent Highlights
Peginterferon Lambda (Lambda) in Hepatitis D Virus (HDV)
- PRIME Designation granted by EMA
- Positive Phase 2 LIMT (Lambda mono therapy) study results (N=33): 36% durable virologic response at 24 weeks post-treatment reported at The International Liver Congress™ 2019
Avexitide in Post-Bariatric Hypoglycemia (PBH) Program
- Breakthrough Therapy Designation granted by
FDA
Corporate Activity
Mark Mannebach , PhD, RPh, appointed as Vice President, Global Regulatory Affairs- Jeysen Yogaratnam, MB.BCh, BAO, MRCSEd, PhD, MBA, appointed as Vice President,
Global HDV Clinical Development
Anticipated 2019 Milestones
- FDA Guidance for Avexitide in PBH
- Phase 2 LIFT (Lambda combination therapy with Lonafarnib and Ritonavir) end-of-treatment study results in HDV at AASLD
- End of Phase 2 meeting for Lambda in HDV
- NDA and MAA submissions in Progeria and Progeroid Laminopathies in Q4 2019
- Phase 3 D-LIVR study in HDV (N=400) enrollment update
Second Quarter 2019 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
Second quarter 2019 operating expenses include total non-cash expenses of
In
As of
About Eiger
Eiger is a late stage biopharmaceutical company focused on the development and commercialization of a pipeline of first-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs and for which no approved therapies exist.
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. The company is rapidly advancing peginterferon lambda, a first-in-class interferon, toward registration for the treatment of HDV. Eiger is preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in Q4 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 submit an NDA and MAA for Progeria and progeroid laminopathies in Q4 2019, present end-of-treatment data in our LIFT study, progress our Phase 3 D-LIVR study in HDV, receive
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
Eiger BioPharmaceuticals Inc. |
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Condensed Consolidated Balance Sheets |
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(in thousands) |
|||||||||
Six Months Ended |
Year Ended |
||||||||
June 30, |
December 31, |
||||||||
2019 |
2018(1) |
||||||||
(unaudited) |
|||||||||
ASSETS |
|||||||||
Cash and cash equivalents |
$ 58,421 |
$ 61,262 |
|||||||
Debt securities, available-for-sale |
66,914 |
39,091 |
|||||||
Prepaid expenses and other current assets |
3,033 |
1,492 |
|||||||
Total current assets |
128,368 |
101,845 |
|||||||
Property and equipment, net |
200 |
167 |
|||||||
Operating lease right-of-use assets |
1,761 |
— |
|||||||
Other assets |
2,598 |
436 |
|||||||
Total assets |
$ 132,927 |
$ 102,448 |
|||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
$ 13,317 |
$ 10,024 |
|||||||
Other liabilities |
31,531 |
25,832 |
|||||||
Stockholders' equity |
88,079 |
66,592 |
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Total liabilities and stockholders' equity |
$ 132,927 |
$ 102,448 |
|||||||
(1) Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018. |
Eiger BioPharmaceuticals Inc. |
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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 |
|||||||||||||||||||||||||||
June 30, |
June 30, |
|||||||||||||||||||||||||||
(unaudited) |
(unaudited) |
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2019 |
2018 |
2019 |
2018 |
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Operating expenses: |
||||||||||||||||||||||||||||
Research and development(1) |
$ 12,936 |
$ 6,372 |
$ 25,804 |
$ 11,884 |
||||||||||||||||||||||||
General and administrative(1) |
4,225 |
3,237 |
8,282 |
6,231 |
||||||||||||||||||||||||
Total operating expenses |
17,161 |
9,609 |
34,086 |
18,115 |
||||||||||||||||||||||||
Loss from operations |
(17,161) |
(9,609) |
(34,086) |
(18,115) |
||||||||||||||||||||||||
Interest expense |
(869) |
(495) |
(1,634) |
(893) |
||||||||||||||||||||||||
Interest income |
502 |
189 |
1,013 |
283 |
||||||||||||||||||||||||
Other income (expense), net |
1 |
— |
(9) |
(21) |
||||||||||||||||||||||||
Net loss |
$ (17,527) |
$ (9,915) |
$ (34,716) |
$ (18,746) |
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Net loss per common share: |
||||||||||||||||||||||||||||
Basic and diluted |
$ (0.75) |
$ (0.82) |
$ (1.63) |
$ (1.66) |
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Shares used to compute net loss per common share: |
||||||||||||||||||||||||||||
Basic and diluted |
23,408,652 |
12,045,355 |
21,338,551 |
11,291,540 |
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(1) Includes stock-based compensation expense of: |
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Three Months Ended |
Six Months Ended |
|||||||||||||||||||||||||||
June 30, |
June 30, |
|||||||||||||||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||||||||||||||
Research and development |
$ 442 |
$ 471 |
$ 807 |
$ 794 |
||||||||||||||||||||||||
General and administrative |
1,045 |
850 |
1,875 |
1,530 |
||||||||||||||||||||||||
Total stock-based compensation expense |
$ 1,487 |
$ 1,321 |
$ 2,682 |
$ 2,324 |
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