Eiger BioPharmaceuticals, Inc.

Good day, ladies and gentlemen, and welcome to the Iger Biopharmaceutical Second 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 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 Rayali, 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 Q2 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, our 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 be available for the Q&A portion of the call. I would like to remind investors that this call will include forward-looking statements within the meeting of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including but not limited to the types of statements identified as forward-looking in our 2020 Annual Report on Form 10-K, our quarterly reports on Form 10-Q, and our subsequent periodic reports filed with the SEC, which will all be available on our website in the Investors section. For a further description of the risks and uncertainties that could cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, please see our periodic reports filed with the SEC. These forward-looking statements represent our views only as of the date of this call and involve substantial risks and uncertainties, including many that are beyond our control and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update such statements. I'll now turn the call over to David.

Thanks, Sri. Good afternoon, everyone, and thank you for joining us today. We are making great progress across our pipeline, which includes multiple late-stage therapies for rare diseases. We are very proud at Iger that every one of our rare disease programs now has FDA breakthrough therapy designation. And these include lonafarnib and PEG interferon lambda for hepatitis delta virus infection, Avexatide for post-bariatric hypoglycemia and now congenital hyperinsulinism, and Zokinvi for progeria, which is now commercially approved. Iger is well positioned to advance several catalysts for value creation in 2021 and beyond. We look forward to updating you today on our progress and future plans. Our lead clinical development programs are focused on hepatitis delta virus, 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. Sadly, 60% of HDV patients die within 10 years after diagnosis. This is a large orphan disease in the US and Europe with an urgent unmet medical need. There is no FDA approved therapy for hepatitis delta virus. Iger is pioneering the development of treatments in this space. We are 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 progression of disease, which has been shown to lead to improved outcomes. Importantly, this is consistent with FDA guidance for development of HDV therapies. Additionally, HDV therapies will require chronic dosing. Convenient administration for long-term treatment could improve compliance and outcomes, which are critical to both patients and physicians. We believe that lonafarnib, a daily oral medication, and PEG interferon lambda, a weekly subcutaneous injection, offer the most convenient dosing compared to other late-stage HDV programs in development. At Iger, we are advancing an HDV platform strategy that provides multiple paths 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. Lonifarnib, the only oral treatment in development for HDV, is currently dosing in the Phase III DELIVER study. DELIVER is the largest global Phase III study to be conducted in HDV, with over 100 sites across 20 countries. The DELIVER study design opens the door to deliver a win for HDV patients with the all-oral lonifarnib-based regimen and in combination with PEG interferon-alpha, we are pleased to see continued momentum in DELIVER, which is now over 90% enrolled. This includes patients randomized to date and patients in screening that are expected to be randomized. We are on track to complete enrollment before end of 2021, setting up for pivotal top-line data release in late 2022. Our second therapy in development for HDV is PEG interferon-Lambda, a well-tolerated interferon, which is beginning phase 3. We have concurrence with FDA and EMA for a single pivotal study called Limit 2, and we expect to enroll our first patient in this study before the end of the year. Limit 2 represents an efficient pathway for PEG interferon lambda approval in HDV, and we are excited to begin this study. For over a decade, Iger has been engaged in the clinical development of therapies for viral hepatitis. we have gained a deep understanding of the needs of HDV patients and of physicians who care for them. We believe that lonafarnib and PEG interferon lambda will become foundational therapies to be used alone and in combination for the treatment of HDV. Iger is well positioned to be a leader in HDV, a billion dollar plus commercial market opportunity. Beyond HDV, we continue to advance the rest of our rare disease pipeline. Avexetide is a novel first-in-class targeted therapy for two very different orphan metabolic disorders, post-bariatric hypoglycemia, which has been granted FDA breakthrough therapy designation, and congenital hyperinsulinism, which has been granted FDA breakthrough therapy designation and rare pediatric disease designation. We plan to complete manufacturing and device development as well as regulatory activities this year to support registration enabling clinical trials as early as 2022 for both indications. Avexatide represents a significant commercial opportunity and we will provide guidance in the future on how we plan to advance this program. While we remain focused on our mission to develop and commercialize targeted therapies for serious rare and ultra 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. Positive results from this study could support a submission for emergency use authorization. We look forward to reporting interim futility data analysis potentially by year end. Turning to our first approved product, we were pleased that Zoe Kinvey was the recipient of the 2021 National Organization of Rare Disorders Industry Innovation Award and is now a nominee for the 2021 PreGallion USA Best Pharmaceutical Agent Award. The U.S. launch of Zokinvi continues to progress very well, and we expect EMA approval later this year. Zokinvi has demonstrated our ability to go from IND to NDA to approval and launch, and to successfully navigate complex global regulatory landscapes. Importantly, we have established 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. Before turning the call over to Ingrid to discuss our clinical development programs in more detail, I'd like to note that we ended the quarter with approximately $140 million in cash and investments, enough to fund our planned Phase III HDV studies and sufficient runway to fund planned operations into Q4 2023. Ingrid?