Eiger BioPharmaceuticals Reports First Quarter 2019 Financial Results and Provides Business Update
"Eiger is on track to file the first-ever NDA and MAA for Progeria and Progeroid Laminopathies in 2019," said
Recent Highlights
Hepatitis D Virus (HDV) Program
Lonafarnib in HDV
- Lonafarnib+Ritonavir patent portfolio expanded to include US,
Europe andJapan
Peginterferon Lambda (Lambda) in HDV
- 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
- Positive Phase 2 PREVENT 28-day study results (N=18) reported at
ENDO 2019
Corporate Activity
$53.2 million raised in net proceeds from underwritten public offering inApril 2019 Amit K. Sachdev , JD, market access, public policy expert and biotech veteran appointed to Board of DirectorsStephana Patton , PhD, JD, pharma industry veteran, appointed as Eiger 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 of Directors
Anticipated 2019 Milestones
- Phase 3 D-LIVR study in HDV (N=400) site activation and enrollment
- Phase 2 LIFT (Lambda combination therapy with Lonafarnib+Ritonavir) end-of-treatment study results in HDV at AASLD
- NDA and MAA submissions in Progeria and Progeroid Laminopathies
- End of Phase 2 meeting for Avexitide in PBH
- End of Phase 2 meeting for Lambda in HDV
First 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
Total first quarter 2019 operating expenses include 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 also rapidly advancing peginterferon lambda, a first-in-class interferon, toward a Phase 3 study 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 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, present end-of-treatment data in our LIFT study and progress our Phase 3 study in HDV, hold an end of Phase 2 meeting for avexitide in PBH and hold an end of Phase 2 meeting for peginterferon lambda 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. 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 year ended
Investors:
Email: [email protected] / Phone: 1-650-619-6115
Eiger BioPharmaceuticals Inc. |
|||||||||
Condensed Consolidated Balance Sheets |
|||||||||
(in thousands) |
|||||||||
Three Months Ended |
Year Ended |
||||||||
March 31, |
December 31, |
||||||||
2019 |
2018(1) |
||||||||
(unaudited) |
|||||||||
ASSETS |
|||||||||
Cash and cash equivalents |
$ 63,407 |
$ 61,262 |
|||||||
Debt securities, available-for-sale |
22,385 |
39,091 |
|||||||
Prepaid expenses and other current assets |
2,594 |
1,492 |
|||||||
Total current assets |
88,386 |
101,845 |
|||||||
Property and equipment, net |
155 |
167 |
|||||||
Operating lease right-of-use assets |
1,861 |
— |
|||||||
Other assets |
2,706 |
436 |
|||||||
Total assets |
$ 93,108 |
$ 102,448 |
|||||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
$ 10,825 |
$ 10,024 |
|||||||
Other liabilities |
31,475 |
25,832 |
|||||||
Stockholders' equity |
50,808 |
66,592 |
|||||||
Total liabilities and stockholders' equity |
$ 93,108 |
$ 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 |
||||||||||
(in thousands, except per share and share amounts) |
||||||||||
Three Months Ended |
||||||||||
March 31, |
||||||||||
(unaudited) |
||||||||||
2019 |
2018 |
|||||||||
Operating expenses: |
||||||||||
Research and development(1) |
$ 12,868 |
$ 5,512 |
||||||||
General and administrative(1) |
4,057 |
2,994 |
||||||||
Total operating expenses |
16,925 |
8,506 |
||||||||
Loss from operations |
(16,925) |
(8,506) |
||||||||
Interest expense |
(765) |
(398) |
||||||||
Interest income |
511 |
94 |
||||||||
Other expense, net |
(10) |
(21) |
||||||||
Net loss |
$ (17,189) |
$ (8,831) |
||||||||
Net loss per common share: |
||||||||||
Basic and diluted |
$ (0.90) |
$ (0.84) |
||||||||
Shares used to compute net loss per common share: |
||||||||||
Basic and diluted |
19,168,448 |
10,529,350 |
||||||||
(1) |
Includes stock-based compensation expense of: |
|||||||||
Three Months Ended |
||||||||||
March 31, |
||||||||||
2019 |
2018 |
|||||||||
Research and development |
$ 365 |
$ 323 |
||||||||
General and administrative |
830 |
680 |
||||||||
Total stock-based compensation expense |
$ 1,195 |
$ 1,003 |
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