Atea Pharmaceuticals(AVIR)

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Atea Pharmaceuticals(AVIR) - 2024 Q1 - Quarterly Results
2024-05-14 20:16
Exhibit 99.1 Atea Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update Full Enrollment Achieved in Global Phase 3 SUNRISE-3 Trial for Treatment of COVID-19 with Results Expected 2H'24 Global Phase 2 HCV Study On Track to Report Complete SVR12 Results 2H'24 Multiple Presentations Showcasing Preclinical and New Phase 2 Ef icacy Data to be Presented at European Association for the Study of the Liver (EASL) Congress 2024 Conference Call at 4:30 pm ET Today BOSTON, Mass., May ...
Atea Pharmaceuticals to Host First Quarter 2024 Financial Results Conference Call on May 14, 2024
Newsfilter· 2024-05-07 11:00
BOSTON, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that it will host a live conference call and audio webcast on Tuesday, May 14, 2024, at 4:30 p.m. ET to report financial results for the first quarter ended March 31, 2024, and to provide a business update. To access the live conference call, participant ...
Atea Announces Presentation of Data Highlighting Favorable Safety Profile of Bemnifosbuvir at ESCMID Global 2024
Newsfilter· 2024-04-29 11:00
Core Viewpoint - Atea Pharmaceuticals presented Phase 1 data for bemnifosbuvir, an oral antiviral, at ESCMID 2024, highlighting its favorable safety profile and lack of cardiotoxicity, aiming to address unmet needs in COVID-19 and hepatitis C treatment [1][2][3]. Group 1: Bemnifosbuvir for COVID-19 - Bemnifosbuvir is an oral nucleotide polymerase inhibitor targeting SARS-CoV-2, with a unique mechanism of action that may create a high barrier to resistance [5]. - The global Phase 3 SUNRISE-3 trial has enrolled over 2,200 high-risk patients, focusing on all-cause hospitalization or death as the primary endpoint [4]. - Results from the Phase 1 study indicated no clinically relevant effects on cardiac repolarization or heart rate, confirming preclinical findings of low cardiotoxicity [3][4]. Group 2: Bemnifosbuvir for Hepatitis C Virus (HCV) - Atea is conducting a Phase 2 trial of bemnifosbuvir in combination with ruzasvir for treatment-naïve HCV patients, with a primary endpoint of sustained virologic response at Week 12 post-treatment [6][7]. - In the lead-in cohort of 60 patients, a 98% sustained virologic response rate was observed, indicating strong efficacy [7]. - Bemnifosbuvir has shown to be significantly more active than sofosbuvir against various HCV genotypes, with a favorable pharmacokinetic profile supporting once-daily dosing [8]. Group 3: Company Overview - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral infections, leveraging a proprietary nucleos(t)ide prodrug platform [10]. - The company aims to expand its pipeline by integrating other classes of antivirals alongside its nucleos(t)ide candidates [10].
Atea Pharmaceuticals(AVIR) - 2023 Q4 - Earnings Call Transcript
2024-02-29 04:24
Financial Data and Key Metrics Changes - The company reported a cash, cash equivalents, and marketable securities balance of $578.1 million as of December 31, 2023, with a runway anticipated to 2026 [11][26]. - Research and development expenses increased for both the fourth quarter and full year 2023 compared to the same periods in 2022, primarily due to external spending related to COVID-19 and HCV clinical trials [26]. Business Line Data and Key Metrics Changes - For the COVID-19 program, the company achieved significant progress in the Phase 3 SUNRISE-3 study, surpassing enrollment of 1,400 patients, which triggered a second interim analysis [9][20]. - In the HCV program, the company confirmed a 98% sustained virological response (SVR4) in the leading cohort of its Phase 2 study, with plans to expand enrollment to 280 patients [10][12]. Market Data and Key Metrics Changes - The U.S. prescription demand for oral antivirals to treat COVID-19 was robust, with approximately 7.7 million prescriptions written in 2023, reflecting a strong market opportunity [24][25]. - The projected annual global market opportunity for COVID-19 oral antivirals is estimated to be over $4 billion to $5 billion, indicating significant unmet needs in the market [25]. Company Strategy and Development Direction - The company aims to develop antiviral drugs for serious viral diseases with significant unmet medical needs, focusing on COVID-19 and HCV treatments [8][10]. - The strategy includes leveraging the Fast Track designation from the FDA for bemnifosbuvir, which is expected to address key limitations of current COVID-19 therapies [6][10]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for effective COVID-19 treatments, especially given the emergence of new variants and the limitations of existing therapies [8][19]. - The company anticipates a transformational milestone-rich 2024, with key clinical milestones expected for both the COVID-19 and HCV programs [28]. Other Important Information - The company is conducting Phase 1 studies in the U.S. for the selection of a fixed-dose combination tablet for HCV, with a Phase 3 program anticipated to begin around the end of the year [17][28]. - Management highlighted the importance of developing a best-in-class regimen for HCV that minimizes drug-drug interactions, particularly for patients co-infected with HIV [35][38]. Q&A Session Summary Question: Visibility on patient accrual in SUNRISE-3 - Management indicated that the majority of patients are being assigned to the monotherapy arm due to concerns about drug interactions with combination therapies [33][34]. Question: Significance of non-protease-based inhibitor option for HCV - Management emphasized the importance of being protease-free to reduce drug-drug interactions, particularly for HIV co-infected patients [35][36]. Question: Capital allocation strategy for COVID and HCV programs - Management stated that expenses are expected to increase in a measured way, with preparations for commercialization activities as the Phase 3 programs progress [40][42]. Question: Scenarios for SUNRISE-3 top line data - Management acknowledged the potential impact of preexisting immunity on efficacy and emphasized the importance of the study design to maximize results [44][45]. Question: Ensuring compliance in HCV Phase 3 trial - Management plans to address compliance issues by offering a shorter treatment duration and regular patient follow-ups, with a comparator arm to assess adherence [49][51].
Atea Pharmaceuticals(AVIR) - 2023 Q4 - Earnings Call Presentation
2024-02-29 01:56
Fourth Quarter and Full Year 2023 Financial and Business Update February 28, 2024 June 2020 NASDAQ: AVIR DISCLAIMERS Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies ...
Atea Pharmaceuticals(AVIR) - 2023 Q4 - Annual Results
2024-02-27 16:00
Exhibit 99.1 Atea Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Final Results Confirm 98% Sustained Virologic Response Rate at Week 4 Post-Treatment (SVR4) from Lead-in Cohort in Phase 2 HCV Study Enrollment in Phase 3 SUNRISE-3 Study Has Surpassed 1,400 COVID-19 Patients in Monotherapy Population; Two Interim Analyses by Independent Data Safety Monitoring Board (DSMB) Planned for 1H'24 with Topline Results Expected 2H'24 Conference Call at 4:30 pm ...
Atea Pharmaceuticals(AVIR) - 2023 Q4 - Annual Report
2024-02-27 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39661 | --- | --- | |---------------------------------------------------------------------------------------------------------|------ ...
Atea Pharmaceuticals Announces Positive Initial Data from Phase 2 Study for Hepatitis C Virus (HCV) and Significant Enrollment Milestone for Phase 3 SUNRISE-3 Trial for COVID-19
Newsfilter· 2024-01-08 21:05
Core Insights - Atea Pharmaceuticals has achieved significant clinical milestones in its Hepatitis C Virus (HCV) and COVID-19 programs, reporting a 98% Sustained Virologic Response at Week 4 (SVR4) from the initial data of 52 patients in a Phase 2 study for HCV treatment and surpassing 650 patients enrolled in the Phase 3 SUNRISE-3 trial for COVID-19 [1][2][5] HCV Program - The Phase 2 study of bemnifosbuvir and ruzasvir (RZR) showed a 98% SVR4 rate, exceeding the efficacy criterion of >90% for continuing the study, with topline results expected in Q3 2024 [2][3] - The study enrolled 60 direct acting antiviral naïve, non-cirrhotic patients, with preliminary data available from 52 patients, indicating rapid viral load reduction and good tolerability of the treatment [3][4] - The trial aims to enroll approximately 280 treatment-naïve HCV-infected patients, with full enrollment expected by mid-2024 [4] COVID-19 Program - The SUNRISE-3 trial has enrolled over 650 patients, allowing for the first interim analysis by the independent Data Safety Monitoring Board (DSMB) expected in March 2024 [1][5] - This Phase 3 trial is a global, multicenter, randomized, double-blind, placebo-controlled study evaluating bemnifosbuvir in high-risk COVID-19 patients, with hospitalization as the primary endpoint [6][7] - The trial includes two study populations based on the type of standard of care received, with a primary endpoint of all-cause hospitalization or death through Day 29 post-treatment in 2,200 patients [8] Drug Mechanism and Efficacy - Bemnifosbuvir is a nucleotide polymerase inhibitor showing approximately 10-fold more activity than sofosbuvir against various HCV genotypes and remains effective against resistance-associated strains [9] - Ruzasvir has demonstrated potent antiviral activity in preclinical studies and has been well-tolerated in prior clinical trials [10] - For COVID-19, bemnifosbuvir targets the SARS-CoV-2 RNA polymerase, showing efficacy against all tested variants of concern [11] Company Overview - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral infections, leveraging its expertise in antiviral drug development and nucleos(t)ide chemistry [12][13]
Atea Pharmaceuticals(AVIR) - 2023 Q3 - Earnings Call Presentation
2023-11-11 10:28
Third Quarter 2023 Financial and Business Update November 8, 2023 DISCLAIMERS Forward-Looking Statements This presenta,on contains “forward-looking statements” within the meaning of the Private Securi,es Li,ga,on Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expecta,ons and assump,ons regarding the future of our business, future plans and strategies, our clinical results and other future condi ...
Atea Pharmaceuticals(AVIR) - 2023 Q3 - Earnings Call Transcript
2023-11-08 23:51
Financial Data and Key Metrics Changes - As of September 30, 2023, the company reported cash and cash equivalents of $595.1 million, with a cash runway extending well into 2026 [10][23]. - General and administrative expenses remained consistent year-over-year, while research and development expenses increased due to advancements in COVID-19 and HCV clinical programs [23]. Business Line Data and Key Metrics Changes - The COVID-19 program is progressing well, with enrollment in the SUNRISE-3 trial reflecting global infection rates and a strong patient enrollment trend, particularly in the U.S. [7][13]. - The HCV program has completed enrollment of the 60-patient leading cohort in its Phase II combination study of bemnifosbuvir and ruzasvir, with initial results expected in early 2024 [10][20]. Market Data and Key Metrics Changes - The U.S. market for COVID-19 oral antivirals is projected to be a multibillion-dollar opportunity, with an estimated annual global market of approximately $10 billion [18]. - The global net sales market for hepatitis C was approximately $3.5 billion in 2022, with the U.S. representing roughly 50% of that market [47]. Company Strategy and Development Direction - The company aims to deliver effective treatments for COVID-19 and HCV, addressing unmet medical needs with a focus on safety and tolerability [8][10]. - Atea Pharmaceuticals is pursuing a multipronged approach against COVID-19, including the development of a second-generation protease inhibitor [9]. Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing evolution of COVID-19 variants and the urgent need for new oral antivirals, emphasizing the potential of bemnifosbuvir to address current treatment limitations [12][13]. - The company anticipates that 2024 will be transformational, with several key data readouts expected [24]. Other Important Information - The company has received fast track designation for bemnifosbuvir, reflecting the recognized unmet medical need for COVID-19 patients [16]. - Atea plans to present supportive data for bemnifosbuvir and ruzasvir at the 2023 Annual Meeting of the American Association for the Study of Liver Diseases [22]. Q&A Session Summary Question: Enrollment pace and interim analysis for SUNRISE-3 - Management confirmed that the first interim analysis is on track for Q1 2024 and emphasized confidence in enrollment pace due to a broad geographical footprint [28][30]. Question: Context of SUNRISE-3 in competitive landscape - Management believes hospitalization is the most important benefit and highlighted differences in trial populations compared to competitors [35][37]. Question: Efficacy communication timeline for SUNRISE-3 - Management indicated that the unpredictable nature of COVID surges makes it difficult to estimate when efficacy data could be communicated [40]. Question: Interim DSMB analysis announcement - Management stated that the announcement will confirm whether the study can continue or not, without providing initial safety data [52].