“Eiger begins 2020 with four late-stage, FDA Breakthrough Therapy Designation Programs, withfirst-in-class therapies, targeting rare and ultra-rare diseases with high unmet medical needs with no approved treatments,” said David Cory, President and CEO of Eiger. “We are focused on commercial preparation for an anticipated approval of Lonafarnib in Progeria and Progeroid Laminopathies in 2020 and HDV market development as we prepare for Phase 3 data from ourD-LIVR trial in 2021.”
Financial Guidance
At December 31, 2019, the Company had approximately $95M in cash, cash equivalents and investments. The company expects 2020 cash burn for planned operations to be generallyin-line with 2019 burn.
About Eiger
Eiger is a late-stage biopharmaceutical company focused on the development and commercialization offirst-in-class, well-characterized drugs for serious rare and ultra-rare diseases for patients with high unmet medical needs, for which no approved therapies exist.
Eiger has initiated a rolling New Drug Application (NDA) submission process for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies. The company’s lead program is in Phase 3, developing lonafarnib, afirst-in-class oral prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. The company is also advancing peginterferon lambda, afirst-in-class interferon, toward registration for the treatment of HDV. 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 completion of a rolling NDA submission by first quarter 2020, followed by submission of an MAA in first quarter 2020 for lonafarnib in Progeria and Progeroid Laminopathies; our progression and enrollment of our Phase 3D-LIVR study in HDV; our planned advancement of Lambda and lonafarnib boosted with ritonavir for HDV; our
