Core Insights - Atea Pharmaceuticals announced new data supporting the combination regimen of bemnifosbuvir and ruzasvir as a potential best-in-class treatment for hepatitis C (HCV) at The Liver Meeting 2025 [1][2] - The company is advancing its global Phase 3 program, with patient enrollment ongoing, and is optimistic about reshaping the standard of care for HCV [2][8] Clinical Data and Presentations - Three abstracts will be presented at The Liver Meeting 2025, including results from a Phase 2 study and a Phase 1 study on the fixed-dose combination [1][2] - The Phase 2 study showed a 98% sustained virologic response (SVR12) in the treatment-adherent population and a 95% SVR12 in the efficacy evaluable population [4][5] - The combination regimen demonstrated high relative bioavailability and can be dosed without regard to food [4][5] Ongoing Trials - Atea's Phase 3 development program includes two trials: C-BEYOND in the US and Canada, and C-FORWARD outside North America, each enrolling approximately 880 treatment-naïve patients [9][10] - The primary endpoint for these trials is HCV RNA below the lower limit of quantitation at 24 weeks, ensuring consistent measurement across all patients [10] Market Context and Challenges - HCV remains a significant global healthcare issue, with approximately 50 million people chronically infected worldwide and an estimated 240,000 deaths annually [11] - In the US, between 2.4 and 4 million people are estimated to have HCV, with new infections outpacing treatment rates [11] Drug Profile - Bemnifosbuvir has shown to be approximately 10-fold more active than sofosbuvir against various HCV genotypes and has a favorable safety profile [12] - Ruzasvir has demonstrated potent antiviral activity and a favorable safety profile in clinical studies [12] Upcoming Events - Atea will host a virtual key opinion leader (KOL) investor event on November 13, 2025, to discuss the HCV commercial market opportunity and ongoing clinical development [6][8]

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]

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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 had $454.7 million in cash, cash equivalents, and marketable securities, projecting a cash runway into 2028 [11][36] Business Line Data and Key Metrics Changes - The global phase two trial for the HCV program demonstrated a 98% cure rate in the primary efficacy analysis with an eight-week treatment [7] - The regimen of bemnifosbuvir and ruzasvir is expected to disrupt the global HCV market, which approximates $3 billion in annual net sales [8][15] Market Data and Key Metrics Changes - In the United States, there are between 2.4 to 4 million untreated HCV patients, with only approximately 100,000 patients treated out of 160,000 new infections annually [13][14] - Treated patients in the U.S. resulted in approximately $1.5 billion in net sales last year [15] Company Strategy and Development Direction - The company is initiating a global phase three program for the HCV regimen, with enrollment expected to begin next month [10] - The company has retained Evercore to assist in exploring strategic partnerships related to the phase three HCV program [9] - A workforce reduction of approximately 20-25% was announced to enhance efficiency, expected to result in cost savings of approximately $15 million through 2027 [37] Management's Comments on Operating Environment and Future Outlook - Management believes the global phase three HCV program is de-risked with a compelling value proposition based on substantial preclinical and clinical data [39] - The company aims to become the most prescribed treatment for hepatitis C, potentially disrupting a multibillion-dollar market [40] Other Important Information - The company appointed Arthur Kirsch 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 the 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? - Additional data regarding efficacy and safety is expected to be presented at EASL 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 that number based on enrollment [55][58] Question: How does the modeling compare to Epclusa in the non-cirrhotic population? - The model has been developed by Dr. Alan Perelson, and comparisons with other direct-acting antivirals for HCV can be referenced in their publications [60]

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]