Eiger BioPharmaceuticals, Inc.

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, 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 Q2 financial results, which is also available on our website at igobio.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 Riali, Chief Financial Officer, Eldon Mayer, Chief Commercial Officer, and Dr. Ingrid Chung, Senior Vice President, Clinical Development. We also have subject matter experts on our team, Dr. Colin Hyslop, Senior Vice President, Clinical and Development Operations, and Dr. Colleen Craig, Vice President, Metabolic Diseases, available for Q&A. Before we begin, I'd 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 eyes of control, which could cause or impact your results to differ materially. A description of these risks and uncertainties is contained in IGA's filings with the SEC, including our latest 10-K and 10-Q reports available on the IGA website in the investor section. All forward-looking statements are based on information currently available to IGA, and we assume no obligation to update these statements. I'll now turn the call over to David.

Thanks, Sarah. As we enter the second half of 2022, Momentum continues to build across all of our programs, with multiple upcoming value-creating milestones. These clearly position Iger as a highly differentiated biopharmaceutical company with a diverse pipeline. With major catalysts in our development programs for PEG-interferon lambda, lonafarnib, and avexatide, as well as on the commercial front with Zokinbi, we believe that 2022 is shaping up to be a transformational year for Iger. I'll begin with progress on our PEG Interferon Lambda program for COVID-19. Since we announced positive top line results from the phase three investigator-sponsored TOGETHER study in March, our team has been actively engaged with the FDA on a potential emergency use authorization application and have provided responses to all of the agency's information requests during this time. As we continue to see the rise of new variants, including the new BA.5 sub-variant, it is clear that while the COVID-19 threat is evolving, it continues to be a burden to the public health system and the need for more effective medicines persists. The TOGETHER study demonstrated that despite widespread vaccination, there remains significant risk of morbidity and mortality from COVID-19, especially for vulnerable patient populations. We believe PEG interferon-Lambda represents an effective one and done therapeutic that is potentially agnostic to the shifting variant landscape, and that if authorized, could play a meaningful role in the COVID-19 response. Given the ongoing need, making PEG interferon lambda available to the healthcare community continues to be our priority. In terms of commercial readiness, we have launch quantities to support the introduction of PEG interferon lambda should the FDA grant emergency use authorization. And as previously communicated, we are actively planning for expanded production capacity. Turning now to our hepatitis delta virus program, we continue to advance our HDV platform with lonafarnib and PEG interferon lambda, both in phase three. We are actively preparing for top-line data from the phase three deliver study of lonafarnib-based regimens by the end of this year, a significant upcoming milestone for Iger and for patients with HDV. With hepatitis delta virus affecting over 12 million people worldwide, the healthcare and economic burden is enormous. We're developing first-in-class therapies to treat this devastating disease. The commercial opportunity in the U.S. and Europe alone is estimated to be more than $1 billion, and we believe both Lonefarnib and PEG interferon lambda have real momentum in phase three, providing opportunities for significant long-term value creation. Ingrid will provide more details on the continued progress in both of these Phase III programs shortly. Now turning to our rare metabolic disease programs, we're advancing Avexatide into the Phase III Avant Registrational Program for congenital hyperinsulinism. Avexatide has been granted FDA breakthrough therapy designation and rare pediatric disease designation, making it eligible for a priority review voucher upon approval. Avexitide is an exciting opportunity for Iger, and most importantly, has the potential to transform the lives of children born with this life-threatening condition. Now finally, turning to our commercial product. We were delighted recently to announce European approval of Zokenvi to treat children and young adults with Hutchinson-Gilford Progeria Syndrome and processing-deficient progeroid laminopathies, collectively known as Progeria. As the world's first and only treatment for Progeria, Zokendi's European approval is an important milestone to the Progeria community. As Iger's first approval in Europe, this is also a significant achievement for our company, establishing our footprint in Europe and demonstrating our ability to navigate ex-US regulatory requirements. We're also expanding global commercial access to Zokendi through strategic partnerships in countries like Japan, with our recently announced partnership with Anges. Elden will provide more details on our commercial progress in just a few moments. This is an exciting time for Iger. 2022 has already been successful as we've achieved key milestones, which further reinforces our confidence in our ability to execute. And we're making great progress as we prepare for critical catalysts during the remaining half of this year. We remain focused on our operational plan to drive growth by advancing our pipeline, leveraging our commercial capabilities to expand our reach, and strengthening the foundation of our business. The progress we have seen this year is reflected across all of these objectives. Going forward, we will continue to leverage our internal capabilities and capitalize on our strengths in a cost-efficient manner to position Iger for sustained growth. I believe this will create value for our shareholders and fulfill unmet needs for patients with serious diseases in need of treatment options. And now I'll hand the call over to Ingrid to review our clinical development progress.