Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update.

PALO ALTO, Calif: Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, today reported financial results for fourth quarter and full year 2022 and provided a business update.

"In December, we announced that both our lonafarnib-based treatments met the primary endpoint in our pivotal Phase 3 D-LIVR trial in hepatitis delta virus (HDV), and we look forward to the pre-NDA meeting with the FDA, which we expect by end of Q2," said David Apelian, MD, PhD, Interim CEO, Eiger. "In addition, we have completed screening in our Phase 3 LIMT-2 study and expect to complete enrollment by the end of Q2. We continue to execute on our unwavering mission to develop innovative therapies for patients with rare diseases, with a focus on maintaining a position of readiness and being thoughtful about how best to employ our resources."

Dr. Apelian continued, "On the corporate front, using both internal and external advisors, we continue our program prioritization analyses to assess the most promising drivers for shareholder value. Given the robust nature of this process, we anticipate providing an update in Q2. In addition, we remain focused on preparing for a planned pre-NDA meeting and guidance from FDA on the D-LIVR program in mid-2023."

Business Highlights

Hepatitis Delta Virus Platform

Lonafarnib-Based Regimens for HDV

First-in-class, oral prenylation inhibitor

In December, announced Phase 3 D-LIVR study topline Week 48 data met the primary endpoint

Lonafarnib/ritonavir response rate of 10.1% (p=0.0044)

Lonafarnib/ritonavir in combination with peginterferon alfa response rate of 19.2% (p

Key secondary endpoint of proportion of patients with improvement in histological response rate demonstrated with statistical significance in combination arm vs placebo

Pre-NDA meeting planned by end of Q2

D-LIVR Week 72 data expected to be presented in mid-2023

Peginterferon Lambda for HDV

Potential first-in-class, well-tolerated interferon

Potential to be interferon of choice in HDV combination therapies

Phase 3 LIMT-2 study of peginterferon lambda monotherapy

Anticipate complete randomization by end of Q2 (N=150)

Combination of Peginterferon Lambda and Lonafarnib/Ritonavir for HDV

Combination of Eiger's two proprietary HDV therapies in development

Phase 2 LIFT-2 study in collaboration with National Institutes of Health...