Eiger BioPharmaceuticals, Inc.

Good day, ladies and gentlemen, and welcome to the Iger Biopharmaceuticals First Quarter 2022 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 Sarah Matheson, Senior Vice President of Corporate Affairs at Iger. You may begin.

Thank you. Good afternoon, everyone, 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 Q1 financial results, which is also 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 use slides for the webcast, and a replay will be available on the investor section of our website. Joining me on the call with prepared remarks are David Corey, President and CEO, Sri Riyali, Chief Financial Officer, Eldon Mayer, Chief Commercial Officer, and Dr. Ingrid Jones, Senior Vice President, Clinical Development. We also have subject matter experts from our team, Dr. Colin Hislop and Dr. Colleen Craig, available for Q&A. Before we begin, 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 IGUS control, which could cause our actual results to differ materially. A description of these risks and uncertainties is contained in IGAR's filings to the SEC, including our latest 10-K and 10-Q reports available on the IGAR website in the investor section. All forward-looking statements are based on information currently available to IGAR, and we assume no obligation to update these statements. I will now turn the call over to David.

Thanks, Sarah. These are very exciting times for IGAR. We're making significant advances across our pipeline while strengthening the foundation of our business and expanding our leadership to support future growth, as we believe that 2022 will be a transformational year for the company. I'll begin with our most recent news and progress on our PEG Interferon Lambda program for COVID-19. Since we announced positive top line results from the phase three together study in March, our team has been focused on preparing our emergency use authorization application. This is a priority milestone for us to make Lambda available to the healthcare community, which remains in need of more effective therapeutic options to help vulnerable COVID-19 patients. We are pleased with our ongoing engagement with FDA and look forward to submitting the EUA application. We are excited by the progress and advancement of Lambda for COVID-19 which essentially has been a program driven by investigators in both phase two and phase three as we focused our internal efforts on lambda for hepatitis delta virus infection. Leveraging investigator sponsored studies has enabled us to generate potentially registration enabling data from a large clinical study in a highly capital efficient way. We expect to file our EUA application this quarter. Exact timing will, of course, be contingent on when we receive the full together data set, but based on our current discussions and our state of preparedness, we believe it is appropriate to expect the filing by the end of this quarter. As a reminder, this is the second largest clinical study of a COVID-19 therapeutic, with data from over 1,900 patients, predominantly vaccinated and across a range of SARS-CoV-2 variants. The final review of this extensive and robust data set is nearing completion. and we intend to communicate the full analysis at the time of our EUA submission. In terms of commercial readiness, we have launch quantities to support the introduction of Lambda should the FDA grant emergency use authorization, and we are actively planning for expanded production capacity. As we continue to see new variants across the globe, it is clear that COVID-19 is far from over, especially for vulnerable patient populations. together demonstrated that despite widespread vaccination, there continues to be significant risk for morbidity and mortality from COVID-19. The recent surges of COVID-19 infections in China, Hong Kong, and Europe highlight the ongoing and global threat of this pandemic and the need for an effective, convenient therapeutic. We believe PEG interferon lambda represents an effective one and done therapeutic that is potentially agnostic to the arising variant landscape of COVID-19 and that, if authorized, will be an important addition to the evolving armamentarium of COVID-19 therapeutics. In addition to the exciting news from our COVID-19 program, we continue to execute on our HDV platform, Lona Farnib and Lambda, both in phase three. With HDV affecting over 12 million people worldwide, the healthcare and economic burden is enormous. As first in class therapies to treat and potentially cure this devastating disease, we believe both our product candidates offer opportunities for significant long term value creation. The hepatitis delta commercial opportunity in the US and Europe is estimated to be more than one billion. Ingrid will provide more details on our continued progress in both phase three programs shortly. Turning now to Avexatide. As we announced last week, we are advancing of Exotide into a phase three registrational program for congenital hyperinsulinism by the end of this year. Our team has obtained alignment with FDA on the phase three clinical program. Recently published phase two results from our partners at Children's Hospital of Philadelphia provide important foundational data that support proof of concept in this patient population, which gives us great confidence moving forward. Avexatide has been granted FDA breakthrough therapy designation and rare pediatric disease designation, making it eligible for a priority review voucher upon approval. Most importantly, Avexatide has the potential to transform the lives of children born with this life-threatening condition. A key part of Iger's growth strategy is to advance clinical programs for underserved patients in a capital and resource-efficient manner. I believe our track record Effectively collaborating with investigators and institutions to provide early research and development support has demonstrated our ability to advance our pipeline in a fiscally disciplined manner. I am encouraged to see our strategy proving successful through the following examples. Our landmark Phase III deliver study in HDV is based on Phase II proof of concept clinical trial work performed at the National Institutes of Health. FDA approval of Zokenvy, the first treatment for Progeria, is the result of our partnership with the Progeria Research Foundation. Our phase three Avexatide congenital hyperinsulinism program builds on phase two research conducted at Children's Hospital of Philadelphia. And of course, our pending EUA submission of Lambda for COVID-19 reflects our strong collaboration with Dr. Jordan Feld in phase two and the Together Study team in phase three, This approach has been instrumental in supporting our ability to deliver on our mission, to develop molecules into medicines for patients who need them the most. I'm proud of our continued progress here, which is testament to our team's focus and commitment to this mission. In summary, we entered this year with a clear operational plan for growth, advancing our pipeline, expanding commercial reach for Zocanby, and strengthening the foundation of our business to prepare for the future. We've made progress against all of these objectives with a first quarter of solid execution and are in a strong position to deliver wins for patients and create value for our shareholders. I'll now hand the call over to Ingrid to review our development progress.