Eiger to end development efforts in HDV

On June 29^th 2023, Eiger hosted an unexpected business update call and released a press release where they announced de-prioritization of their HDV program and a shift to focus development efforts on advancing avexitide in Post-Bariatric Hypoglycemia (PBH) and Congenital Hyperinsulinism. Please find the transcript of this call is attached to this email

Key Details:

• Following a portfolio prioritization exercise, Eiger announced their decision to pursue partnership opportunities for their Viral Hepatitis D programs, effectively ending HDV development
  • Eiger’s website pipeline has been updated to show both virology assets, lonafarnib and pegIFN-lambda, under “Partnership Opportunities”; Eiger stated that they are in “active discussion” with potential partners for both viral hepatitis assets
  • Eiger will undergo a 25% reduction in the workforce and reduce out-of-pocket spending related to its HDV development program; According to LinkedIn, Eiger has 52 employees currently
  • Reprioritization is expected to extend cash runway to Q4 2024
• During Eiger’s pre-NDA meeting regarding the potential approval of lonafarnib regimens for HDV, FDA requested additional virology experiments to be conducted prior to the submission of an NDA
  • FDA also requested a confirmatory clinical trial to be underway prior to approval under the accelerated approval pathway
  • 24-wk off-treatment data from the D-LIVR study (N=405) was discussed at this meeting
• David Apelian, MD, PhD, MBA, was appointed permanent CEO after serving as interim CEO since December 2022

CI Assessment:

• This business update follows the unimpressive Ph3 D-LIVR 24-wk off tx data that was presented by Eiger at EASL 2023 last week by Eiger’s key KOL contributor and advisor Dr. Ohad Etzion
  • This update further confirms no significant near-term competitive threats to bulevirtide for the next several years; Replicor is yet to establish a path to commercialization by establishing a Ph2 clinical trial, Janssen has deprioritized its Viral Hepatitis programs, and VIR is not expected to launch in HDV prior to 2030
• In line with Gilead CI assessment’s, the likelihood of approval for lonafarnib regimens in the next few years is extremely low due to the weak 48-wk on-tx efficacy, unimpressive 24-wk off-tx efficacy, sub-par safety data, lack of long-term safety and efficacy data, and absence of ongoing study generating longer term data to support a conditional approval
• Eiger stock continued to fall throughout the day, and is down 7% as of 2 PM EST and down ~31% since their 24-wk off-treatment presentation at EASL. Since last year, their stock is down 90% indicating a lack of investor confidence