Eiger BioPharmaceuticals, Inc.

Good day, ladies and gentlemen, and welcome to the Iger Biopharmaceuticals Third Quarter 2021 Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at the time. If anyone should require operator assistance, please press star, then zero on your telephone. As a reminder, this call will be recorded. I would now like to introduce your host for today, Mr. Sri Riali, Chief Financial Officer of Iger. You may begin, sir.

Good afternoon, and thank you for joining us today. Welcome to our quarterly financial results and business update call. We issued a press release earlier this afternoon with our Q3 financial results, which is available on our website at IgerBio.com. For today's call, we will have prepared remarks from the management team, followed by Q&A. We will be using slides for the webcast, and we'll have a replay available on the investor section of our website. Joining me on the call are David Corey, President and CEO, Eldon Mayer, our Chief Commercial Officer, and Dr. Ingrid Chung, Senior Vice President of Clinical Development. Dr. Colin Hislop, Senior Vice President of Clinical and Development Operations, will join us for the Q&A portion. I would like to remind investors that this call will include forward-looking statements, including expectations concerning financial performance, commercial products, and potential future products in different therapeutic areas and stages of development. The forward-looking statements rely on certain assumptions and involve risks and uncertainties beyond IGERS control, which could cause our actual results to differ materially. A description of these risks and uncertainties is contained in IGERS filings with the SEC. including our latest 10-K and 10-Q reports available on the Iger website in the Investors section. All forward-looking statements are based on information currently available to Iger, and we assume no obligation to update these statements. I'll now turn the call over to David.

Thanks, Sri. Good afternoon, and thank you for joining us today. At Iger, we're focused on the development of innovative therapies to treat and cure hepatitis delta virus infection and other serious rare diseases. We continue to make great progress across our pipeline of multiple late stage therapies. All five of our rare disease programs have FDA breakthrough therapy designation, lonafarnib and PEG interferon lambda for hepatitis delta virus, Avexatide for post-bariatric hypoglycemia and congenital hyperinsulinism, and Zokindi for progeria. This demonstrates a core strength of Iger, our proven ability to advance targeted therapies for serious rare and ultra-rare diseases with urgent unmet medical needs. Iger is well-positioned to advance several near-term value-creating catalysts. Our lead clinical programs are focused on hepatitis delta virus infection, the most severe form of human viral hepatitis. Hepatitis delta virus is always a co-infection with HBV and is found in approximately 6% of HBV-infected patients. However, hepatitis delta virus causes a much more rapid progression of liver disease than HBV alone. 60% of HDV patients die within 10 years after diagnosis. This is a large orphan disease in the U.S. and Europe with an urgent unmet medical need. There is no FDA-approved therapy for HDV. Iger is pioneering the development of treatments in this space. As we discussed before, we're often asked, what would a win look like for HDV patients? HDV is a devastating, rapidly progressive disease. The first goal of therapy is reduction in HDV viral load and reduction in liver inflammation to slow disease progression, which has been shown to lead to improved outcomes. Importantly, this is consistent with FDA guidance for the development of HDV therapies. At Iger, we are advancing an HDV platform strategy that provides multiple pathways to win for patients. We have two well-characterized promising late-stage product candidates in lonafarnib and PEG interferon lambda. Both have different mechanisms of action, are conveniently administered, and should benefit HDV patients alone and in combinations. Lonafarnib, the only oral treatment in development for HDV, is currently dosing in the Phase III DELIVER study. With over 100 sites across 20 countries, DELIVER is the largest phase 3 study to be conducted in HDV. The DELIVER study design opens the door to deliver a win for HDV patients with the all oral lonafarnib based regimen and in combination with PEG interferon alpha. We were very pleased to announce earlier this week that DELIVER is now fully enrolled with over 400 patients, exceeding our target. This is an important milestone for Iger and for HDV patients. Complete enrollment of DELIVER now sets up pivotal top-line data release by the end of 2022. I'd like to thank the patients and investigators and their teams for their ongoing participation in DELIVER, as well as the Iger clinical team and their steadfast efforts to fully enroll DELIVER. We look forward to reporting data from this landmark study. Our second therapy in development for HDV is PEG interferon lambda, a well-tolerated interferon, which is now in a pivotal phase three study called Limit 2. Limit 2 represents an efficient pathway for PEG interferon lambda approval in HDV, and we are now activating clinical trial sites and screening patients. For well over a decade, Iger has been leading the way in the clinical development of therapies for HDV. We have gained a deep understanding of the needs of HDV patients and the physicians who care for them. We believe that Lonefarnib and PEG interferon lambda will have the potential to become foundational therapies for the treatment of HDV. Iger is well positioned to be a leader in HDV, a commercial opportunity projected to be in excess of $1 billion. Beyond HDV, we're advancing the rest of our rare disease pipeline. Avexatide is a novel, first-in-class targeted therapy for two very different orphan metabolic disorders, post-bariatric hypoglycemia and congenital hyperinsulinism. We're on track to complete regulatory activities this year and advance manufacturing necessary to support registration-enabling clinical trials for both indications. We view Avexatide as a significant commercial opportunity and will provide guidance in the future on how we plan to advance this program. While we remain focused on our mission to develop innovative therapies to treat and cure HDV and other serious rare diseases, we have opportunistically, and in a capital efficient manner, explored the potential of PEG interferon lambda as a convenient outpatient treatment for COVID-19. The placebo controlled phase three together study is enrolling and dosing patients across multiple clinical sites in Brazil. We were pleased to announce in September that the Independent Data Safety Monitoring Board recommended continuation of PEG Interferon Lambda, and we look forward to reporting the next interim futility analysis before the end of this year. PEG Interferon Lambda is now the only investigational agent in the TOGETHER study, and positive results from this study could support a submission for emergency use authorization. Resistance due to variance or new strains of SARS-CoV-2 continue to be an ongoing concern with approved vaccines and monoclonal antibody treatments, as well as orals that are currently in development. Peg interferon lambda's mechanism of action of stimulating the host immune response is agnostic to a rising variance, and as such, we believe may be ideally suited to treat newly diagnosed COVID-19 outpatients as a convenient single subcutaneous injection. Now, turning to Zokenvi, we are proud at Iger that our first approved product is for the treatment of progeria, a devastating, universally fatal, ultra-rare pediatric disease of premature aging. The U.S. launch of Zokenvi has progressed well. We're in discussions with the EMA regarding our MAA and expect an opinion around the end of this year. We've also received approval of a cohort ATU program in France. This is an important achievement and will help bring Zokenvy to French patients with Progeria. Ingrid and Elden will provide additional details on our progress in Europe and with the commercial launch. Zokenvy has demonstrated our ability to go from IND to NDA to approval and launch and to successfully navigate complex global regulatory landscapes. We've established important infrastructure along with commercial and medical affairs functions that can scale and grow for additional commercial launches across larger orphan disease indications in the future. Finally, we ended the quarter with $120 million in cash and investments, which should fund our planned operations in the Q4 2023. I'll now turn the call over to Ingrid to discuss our clinical development programs in more detail. Ingrid?