Eiger BioPharmaceuticals Updates on 2020 Progress and 2021 Plans
Lonafarnib in HDV
- First and only oral agent in development for HDV
- Phase 3 D-LIVR study (N=400) enrollment completion planned in 2021
- End of treatment data planned in 2022
Peginterferon Lambda (Lambda) monotherapy in HDV
- Well-tolerated interferon for weekly subcutaneous injection
- Phase 3 LIMT-2 study (N=150) planned start in 2H21
Lambda-Lonafarnib Combination in HDV
- Positive end of study Phase 2 LIFT data presented at AASLD 2020
- Publication expected in 2021
Zokinvy™ for Progeria and Processing-Deficient Progeroid Laminopathies
U.S. FDA approval inNovember 2020 U.S. commercial launch planned inJanuary 2021 - EMA approval expected 2H21
Lambda in COVID-19
- Positive Phase 2 proof of concept data presented at RespiDART 2020
- Data support impact of baseline viral loads on viral clearance with Lambda
- Pre-IND package submitted to FDA with guidance expected in Q1 2021
Corporate
- PRV sale for
$95M expected to close inJanuary 2021 ;Eiger will retain 50% - Pro forma cash, cash equivalents and investments of approximately
$176M , reflecting$128.8M as ofDecember 31, 2020 plus$47.5M from PRV sale proceeds anticipated inJanuary 2021 , expected to fund planned operations through at least Q4 2023
"Our priority in 2021 are our HDV programs, where we plan to complete D-LIVR enrollment and initiate the Lambda Phase 3 LIMT-2 study," said
About
Zokinvy for the treatment of Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and processing-deficient Progeroid Laminopathies is the Company's first FDA approval. A Marketing Authorization Application (MAA) is under review by the European Medicines Agency (EMA). Outside the U.S.,
For additional information about
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 2021, the timing of our ongoing and planned clinical development, including our ability to support the launch of a new product and ship to specialty pharmacies; the sufficiency of our cash, cash equivalents and investments to fund our operations through at least Q4 2023; the expected closing of the sale of our PRV; our development programs for Zokinvy generally; and the potential approval of Zokinvy in jurisdictions outside of the
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