Eiger BioPharmaceuticals, Inc.

Good day, ladies and gentlemen, and welcome to the Iger Biopharmaceuticals 4th Quarter and Full Year 2021 Financial Results and Business Update Conference Call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that 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's conference, Mr. Sri Riali, Chief Financial Officer of Iger. You may begin.

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 Q4 and full year 2021 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 with prepared remarks 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. 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 either's control that should cause our actual results to differ materially. A description of these risks and uncertainties is contained in Iger's 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. We are very excited about 2022, which we believe will be a transformational year for Iger. Our strategy at Iger has been to build a pipeline designed to bring much needed medicines to patients with urgent unmet medical needs and to create value for shareholders. Today, we have a diverse late stage portfolio that includes one approved product and five FDA breakthrough therapy designated programs. The promise of our pipeline is coming into sharper focus in 2022 with two phase three data readouts planned this year first in COVID-19 and then in hepatitis delta virus. At the core of our strategy is our HDV platform, lonafarnib and PEG interferon lambda, both in phase three and both first-in-class therapies to treat and potentially cure HDV. HDV is our primary focus and is expected to be the indication that drives near and long-term value for IGER. HDV is a deadly global disease. impacting more than 12 million people worldwide. Hepatitis Delta virus is always a co-infection with HBV. However, HDV causes a much more rapid progression of liver disease than HBV alone. Fifty percent of HDV patients are cirrhotic at the time of diagnosis. Iger is pioneering the development of treatments in this space with our HDV platform that targets critical host processes involved in viral replication. Lonifarnib, an oral prenalation inhibitor, and Lambda, an immunomodulator, offer different mechanisms of action, are conveniently administered, and should benefit HDV patients alone and in combinations. Lonifarnib, the only oral treatment in development for HDV, is currently dosing in Deliver, a landmark Phase III study. Deliver is expected to generate pivotal results that, if positive, will support registration of two ronopharnib-based regimens for HDV. Deliver has enrolled 407 patients across 116 clinical sites in over 22 countries, including five sites in Ukraine. We are deeply concerned for all those impacted by this conflict, including the Deliver patients, investigators, site staff, and our CRO colleagues. We continue to closely monitor the evolving situation there with our CRO. We believe DELIVER remains more than adequately powered to demonstrate superiority of each lonafarinib-containing arm over placebo, even if patients from Ukraine discontinue from the study. We have also implemented a number of mitigation measures for the 11 DELIVER sites in Russia, which should enable continued participation of these patients in the study. Ingrid will provide more details in a moment. We look forward to reporting top line deliver data by the end of 2022. Our second therapy in development for HDV is Lambda, a well-tolerated interferon, which is now in a pivotal phase three study called Limit 2. We are also pleased to be studying lonafarnib and Lambda in combination in the Lift 2 study conducted at NIH. We expect the first patient to enroll in this phase two study during the first half of this year. We believe the combination of our two proprietary HDV product candidates will achieve our most robust antiviral activity. As has been the case with other viruses, we expect combination therapies will be required to conquer HDV. Our HDV strategy is clear. First, seek regulatory approvals of lonafarnib-based regimens based on the results of the DELIVER study. While DELIVER includes combination with PEG interferon alpha, we will quickly follow with data and regulatory submissions for the approval of Lambda, a well-tolerated interferon, based on the results of the LIMIT2 study. This is an efficient pathway for potential approvals of both Lona Farnes and Lambda for HDV. In parallel, we will generate data through the LIST2 study that we believe will support future use of our proprietary combination for HDV. 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 patients and the physicians who care for them. We believe that Lona Farnab and Lambda will have the potential to become foundational HDV therapies. Iger is well positioned to be a leader in HDV, a commercial opportunity projected to be in excess of $1 billion. Now, turning to COVID-19. The pandemic continues to evolve with over 450 million cases and 6 million deaths around the world thus far. More treatments are urgently needed and we expect data from the phase three together study of Lambda for COVID-19 this month. The study has completed enrollment of over 1800 patients. When complete, together will be among the largest clinical trials conducted of a therapeutic for COVID-19. If the data are positive, we intend to submit an emergency use authorization application to FDA. Resistance due to variants or new strains of SARS-CoV-2 is an ongoing concern with approved vaccines, monoclonal antibody treatments, and recently approved orals. Lambda's mechanism of action of stimulating the host immune response is agnostic to variants, and as such, we believe may be ideally suited to treat newly diagnosed COVID-19 outpatients as a convenient, one and done, subcutaneous injection, alone, or in potential combinations. We're also making good progress across the rest of our rare disease pipeline. Avexatide, a novel first-in-class targeted therapy for two different orphan metabolic disorders, will be phase three ready this year. And with respect to Zokenvy for Progeria, our first year of commercial launch in the US has been a success. In Europe, our MAA is under review and we expect a CHMP opinion in the first half of 2022. Elden will have more details on Zokendi as well as our initial plan for HBV commercialization in just a few moments. Finally, we began 2022 with approximately $106 million in cash and total investments, which should fund planned operations through Q3 2023. I'll now turn the call over to Ingrid to discuss our clinical development programs in more detail. Ingrid?