Eiger BioPharmaceuticals Reports Third Quarter 2019 Financial Results and Provides Business Update
"We are advancing four Breakthrough Therapy Designation programs into late stages, all with first-in-class therapies targeting rare diseases with no approved treatments," said
Recent Highlights
Lonafarnib in Progeria and Progeroid Laminopathies
- Positive pre-NDA meeting with
FDA - Positive pre-MAA meeting with EMA
Peginterferon Lambda (Lambda) in Hepatitis Delta Virus (HDV)
- Late-breaking oral presentation of positive Phase 2 LIFT (lambda + lonafarnib boosted with ritonavir) interim end-of-treatment results accepted for AASLD
- 95% of patients achieved primary endpoint of >2 log reduction in HDV RNA
- >50% of patients were HDV RNA undetectable or BLOQ
- Adverse events were mostly mild to moderate
- Breakthrough Therapy Designation granted by
FDA
Avexitide in Post-Bariatric Hypoglycemia (PBH)
- Positive End of Phase 2 meeting with
FDA for avexitide in PBH
Upcoming Milestones
- Oral presentation of Phase 2 LIFT interim end-of-treatment results in HDV at AASLD
- NDA submission for Progeria and Progeroid Laminopathies by year-end, followed by MAA submission in the first quarter of 2020
- Phase 3 D-LIVR study in HDV (N=400) enrollment update after year-end
- End of Phase 2 meeting for Lambda monotherapy in HDV in the first quarter of 2020
Third Quarter 2019 Financial Results
Cash, cash equivalents, and short-term investments as of
The Company reported a net loss of
Research and Development expenses were
General and Administrative expenses were
Third quarter 2019 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 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 submit an NDA by year-end 2019, followed by an MAA submission in the first quarter of 2020. 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 planned NDA submission by year-end 2019, followed by submission of an MAA in first quarter 2020 for Progeria and Progeroid Laminopathies; our progression and enrollment of our Phase 3 D-LIVR study in HDV; our planned advancement of lambda and lonafarnib boosted with ritonavir for HDV; our plans to hold an end of Phase 2 meeting for Peginterferon Lambda in HDV in first quarter 2020; our plans for continued advancement of avexitide in registration trials; 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. These statements concern product candidates that have not yet been approved for marketing 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
Eiger BioPharmaceuticals Inc. |
|||||
Condensed Consolidated Balance Sheets |
|||||
(in thousands) |
|||||
Nine Months Ended |
Year Ended |
||||
September 30, |
December 31, |
||||
2019 |
2018(1) |
||||
(unaudited) |
|||||
ASSETS |
|||||
Cash and cash equivalents |
$ 19,406 |
$ 61,262 |
|||
Debt securities, available-for-sale |
90,545 |
39,091 |
|||
Prepaid expenses and other current assets |
4,459 |
1,492 |
|||
Total current assets |
114,410 |
101,845 |
|||
Property and equipment, net |
538 |
167 |
|||
Operating lease right-of-use assets |
1,659 |
— |
|||
Other assets |
3,388 |
436 |
|||
Total assets |
$ 119,995 |
$ 102,448 |
|||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||
Current liabilities |
$ 16,745 |
$ 10,024 |
|||
Other liabilities |
31,591 |
25,832 |
|||
Stockholders' equity |
71,659 |
66,592 |
|||
Total liabilities and stockholders' equity |
$ 119,995 |
$ 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. |
||||||||||
Condensed Consolidated Statements of Operations Financial Data |
||||||||||
(in thousands, except per share and share amounts) |
||||||||||
Three Months Ended |
Nine Months Ended |
|||||||||
September 30, |
September 30, |
|||||||||
(unaudited) |
(unaudited) |
|||||||||
2019 |
2018 |
2019 |
2018 |
|||||||
Operating expenses: |
||||||||||
Research and development(1) |
$ 14,059 |
$ 13,196 |
$ 39,863 |
$ 25,080 |
||||||
General and administrative(1) |
4,247 |
3,643 |
12,529 |
9,874 |
||||||
Total operating expenses |
18,306 |
16,839 |
52,392 |
34,954 |
||||||
Loss from operations |
(18,306) |
(16,839) |
(52,392) |
(34,954) |
||||||
Interest expense |
(884) |
(681) |
(2,518) |
(1,574) |
||||||
Interest income |
585 |
371 |
1,598 |
654 |
||||||
Other income (expense), net |
(11) |
5 |
(20) |
(16) |
||||||
Net loss |
$ (18,616) |
$ (17,144) |
$ (53,332) |
$ (35,890) |
||||||
Net loss per common share: |
||||||||||
Basic and diluted |
$ (0.76) |
$ (1.20) |
$ (2.40) |
$ (2.92) |
||||||
Shares used to compute net loss per common share: |
||||||||||
Basic and diluted |
24,437,451 |
14,255,843 |
22,261,715 |
12,290,500 |
||||||
(1) |
Includes stock-based compensation expense of: |
|||||||||
Three Months Ended |
Nine Months Ended |
|||||||||
September 30, |
September 30, |
|||||||||
2019 |
2018 |
2019 |
2018 |
|||||||
Research and development |
$ 559 |
$ 344 |
$ 1,366 |
$ 1,138 |
||||||
General and administrative |
1,090 |
828 |
2,965 |
2,358 |
||||||
Total stock-based compensation expense |
$ 1,649 |
$ 1,172 |
$ 4,331 |
$ 3,496 |
Investors:
Email: [email protected]
Phone: 1-650-619-6115
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