HCV Program & Clinical Trials - Phase 3 trial C-BEYOND (US/Canada) and C-FORWARD (Outside North America) initiated with first patient dosed in April and June 2025 respectively[12] - Phase 2 results showed 98% SVR12 in treatment adherent patients and 95% SVR12 regardless of adherence[28,29] - Phase 2 results also demonstrated 99% SVR12 in non-cirrhotic treatment adherent patients across genotypes and 97% SVR12 regardless of adherence[31,32] Market Opportunity & KOL Insights - Untreated HCV infections in the US range from 24 million to 4 million, with over 170,000 newly reported annual infections exceeding annual cures[16] - The US HCV market is estimated at ~$15 billion in 2024, with a potential market opportunity exceeding $20 billion[19] - KOL panel highlighted the need for simpler, shorter HCV treatments with fewer drug-drug interactions to improve patient adherence and expand the test-and-treat model[49] Financial Status - Cash, cash equivalents, and marketable securities totaled $3797 million as of June 30, 2025, providing a cash runway through 2027[13] - The company authorized and initiated a repurchase of up to $25 million of its common stock in April 2025, with 46 million shares repurchased as of June 30, 2025[9,67] - Net loss for the second quarter of 2025 was $37161 million, compared to $40522 million for the same period in 2024[64]

It's Monday afternoon and I am meeting Donna for the first time in my busy clinic at Boston Healthcare for the Homeless program. Donna can't sit still. She's twisting her scarf and her hands and she appears to be on the verge of tears as she tells me more about her situation.She had been doing great in a treatment program, but was kicked out over an argument. She's been back in the shelter, and then last night, all of her belongings and medication were stolen from underneath her bunk. This is not at all the ...

Atea Pharmaceuticals (AVIR) Q4 2024 Earnings Call March 07, 2025 12:15 AM ET Company Participants Jonae Barnes - Senior Vice President of Investor Relations & Corporate CommunicationsJean-Pierre Sommadossi - Founder, Chairman, CEO & PresidentJanet Hammond - Chief Development OfficerArantxa Horga - Chief Medical OfficerAndrea Corcoran - CFO, Executive VP of Legal & Secretary Conference Call Participants Isabella Camaj - Equity Research AnalystAndy Hsieh - Research Analyst Operator Good afternoon, everybody, ...

Financial Data and Key Metrics Changes - In 2024, R&D expenses declined quarter over quarter but increased year over year, primarily due to higher external spending related to the COVID-19 phase three Sunrise-3 trial and the phase two HCV trial [34] - Interest income decreased quarter over quarter and year over year due to lower investment balances [35] - As of December 31, 2024, the company reported cash, cash equivalents, and marketable securities of $454.7 million, projecting a cash runway into 2028 [11][36] Business Line Data and Key Metrics Changes - The company made significant progress in its HCV program, reporting a 98% cure rate in the primary efficacy analysis from a global phase two trial with an eight-week treatment regimen [7][28] - The phase two trial included 275 treatment-naive patients, achieving a 98% SVR12 rate in adherent patients and a 95% rate regardless of adherence [27] Market Data and Key Metrics Changes - The global HCV market is approximately $3 billion in annual net sales, with a significant number of untreated HCV patients in the U.S. estimated between 2.4 to 4 million [8][13] - In the U.S., approximately 100,000 out of 160,000 new infections are treated annually, resulting in about $1.5 billion in net sales from treated patients [15] Company Strategy and Development Direction - The company is initiating a global phase three program for its HCV regimen, expecting enrollment to begin next month, with a focus on becoming a best-in-class hepatitis C treatment [10][39] - The company has retained Evercore to assist in exploring strategic partnerships related to its phase three HCV program and has taken cost-cutting actions to enhance efficiency [9] Management's Comments on Operating Environment and Future Outlook - Management emphasized the ongoing high rate of HCV infections and the need for new differentiated therapies, highlighting the potential for their regimen to address this healthcare issue [12][14] - The company believes its regimen, if approved, could disrupt the global HCV market and become the most prescribed treatment [40] Other Important Information - The company announced a workforce reduction of approximately 20-25% to enhance efficiency, expected to result in cost savings of about $15 million through 2027 [37] - Arthur Kirsch was appointed as a new independent director, bringing extensive financial and strategic advisory experience to the board [9][37] Q&A Session Summary Question: Any specific callouts from the FDA meeting regarding phase three trial design? - Management indicated that the FDA is fully aligned with their approach of conducting two open-label phase three trials and did not have substantive comments on the trial conduct [46][47] Question: What can be expected in terms of the scope of the phase two readout later this half? - Management expects to present additional data regarding efficacy and safety at the EASL conference in May [49] Question: Estimated number of cirrhotic patients across the two trials? - Management anticipates enrolling just over 10% cirrhotic patients in the trials, with flexibility in adjusting this number based on enrollment [55][58] Question: How does the modeling compare to Epclusa in the non-cirrhotic population? - Management referred to the model developed by Dr. Alan Perelson and suggested checking their publications for comparisons with other direct-acting antivirals [60]