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8/7/2025
listen-only mode. Should you need assistance, please signal a conference specialist by pressing star then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Janae Barnes. Senior Vice President, Investor Relations and Corporate Communications. Please go ahead.
Great, thank you and good afternoon everyone and welcome to Atea Pharmaceutical's second quarter 2025 Financial Results and Business Update conference call. Earlier today, we issued a press release which outlines the topics we plan to discuss. You can access the press release as well as the slides that we'll be reviewing today by going to the investor section of our website at ir.ateafarma.com. With me today from Atea are our Chief Executive Officer and Founder, Dr. John Pearson Medosi, Chief Development Officer, Dr. Janet Hammond, John Vendrica, our Chief Commercial Officer, Dr. Arantxa Horga, our Chief Medical Officer, and Chief Financial Officer and Executive Vice President of Legal, Andrea Corcoran. all of whom will be available for the Q&A portion of today's call. Before we begin the call, and as outlined on slide two, I would like to remind you that today's discussion will contain forward-looking statements that involve risks and uncertainties. These risks and uncertainties are outlined in today's press release and in the company's recent filings with the Securities and Exchange Commission, which we encourage you to read. Our actual results may differ materially from what is discussed on today's call. With that, I'll now turn the call over to Jean-Pierre.
Thank you, Joneigh. Good afternoon, everyone. Thank you for joining us. I will begin on slide three. For the second quarter, we have several clinical and business highlights to review. We made important progress in our HCV program, evaluating the potential best-in-class regimen of Benifazi and Roosevelt. We started dosing patients in our global phase three development program. which is comprised of the two trials, C-Beyond in the U.S. and Canada, and C-Forward outside of North America. At ESO in May, we presented the final results from our global phase two trial. These results demonstrated a 98% cure rate in the primary efficacy analysis with a short eight-week treatment. The very high sustained biological response, which we refer as SVR, or cure rate, demonstrated the robust potency across HCV genotypes. We also presented three phase one studies, and Aretha will review the highlights of these presentations in a few moments. Also in May, we also had a key opinion leader event, for investors featuring a panel of six HCV experts and prescribers. Leaders in hepatology, gastroenterology, infectious disease, and HCV research in the U.S., Canada, and Europe discussed the current challenges experienced by people living with HCV and what a new optimized HCV therapy could provide for prescriber and patients. Janet will review the key takeaway from this event later in this call. In addition to this substantial clinical progress, we have taken steps to further enhance shareholder value. In April, we announced the repurchase of up to 25 million dollars of the company common stock, reflecting the company commitment to return capital to shareholders while maintaining the capacity to complete the Global Phase III HCV program and position Atea for long-term success. We also announced the addition of a new independent director, Dr. Howard Berman, who has over 20 years of entrepreneurial and life science industry experience. We continue as well to explore potential opportunities to enhance shareholder values. Moving to slide four. It has been nearly a decade since the last generation of HCV therapy became available to patients. Since then, patients and their treatment needs have evolved, and we are focused on the successful development of a potential best-in-class regimen to treat and cure today's HCV patients. During the second quarter, We continue to advance our global Phase III HCV program, evaluating the regimen of Benifazio and the Rizanzia. The patient enrollment is on track, and I'm pleased to share with you tonight. And we anticipate top-line results from C-Beyond in mid-2026 and C-Forward at the end of 2026, which is due to longer timelines outside of North America for regulatory approvals of clinical trials. Our regimen, if approved, has the potential to become a best-in-class HCV treatment and disrupt the global HCV market, which is approximately $3 billion in annual death cells. With $379.7 million in cash, cash equivalent, and marketable securities as of June 30, 2025, we are in a strong financial position to execute and complete our Phase III HCV program. And we anticipate our cash runway will extend through 2027. Moving to slide five, HCV remains a significant global healthcare issue with an increasing incidence of infections, despite the availability of direct acting antiviral for the past decade. Currently in the U.S., out of the 170,000 new infections, only approximately 100,000 patients are treated annually. The unrelenting high rate of HCV infection, which is outpacing the stagnant number of patients being treated, underscore the need for a new, differentiated, and optimized therapy. There are between 2.4 and 4 million untreated people infected with HCV in the United States. And let's not forget that in the U.S., as in developed countries, 70% of liver cancer diagnosis results from HCV disease progression. Therefore, low treatments and cure rates for HCV patients have a profound impact, not only on patient's life, but also on the associated healthcare costs in the near future. On slide six, the large burden of untreated HCV disease is also a large untapped commercial opportunity. We believe that the best-in-class profile of our regimen, which is particularly well-suited for a new model of care, which we call test and treat, with seamless diagnosis and treatment for patients infected with HCV, the anticipated removal of access barrier, and future government initiative we see today are arising from the hail can dramatically expand the number of patients cured of this severe viral disease. With that, I will now turn the call over to Irenza Orga, who will review the presentations at EASL and our phase three program. Irenza?
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