1. BOSTON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea together with other members of the Atea management team, will participate in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Tuesday, September 14, 2021 at 2:00 p.m. ET.

    A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering…

    BOSTON, Sept. 07, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea together with other members of the Atea management team, will participate in a fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Tuesday, September 14, 2021 at 2:00 p.m. ET.

    A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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    • In vitro and in vivo data demonstrate favorable safety and potency against multiple dengue virus serotypes supporting ongoing clinical development of AT-752
    • Dengue is the fastest-spreading mosquito-borne viral disease with an estimated 400 million infections each year globally

    BOSTON, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced the publication of data demonstrating the in vitro and in vivo activity of AT-752 against dengue virus infection, in the journal, Antimicrobial Agents and Chemotherapy. The article titled, "Evaluation of AT-752, a double prodrug of a guanosine nucleotide analog with in vitro and in vivo activity against dengue and other…

    • In vitro and in vivo data demonstrate favorable safety and potency against multiple dengue virus serotypes supporting ongoing clinical development of AT-752
    • Dengue is the fastest-spreading mosquito-borne viral disease with an estimated 400 million infections each year globally

    BOSTON, Aug. 24, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced the publication of data demonstrating the in vitro and in vivo activity of AT-752 against dengue virus infection, in the journal, Antimicrobial Agents and Chemotherapy. The article titled, "Evaluation of AT-752, a double prodrug of a guanosine nucleotide analog with in vitro and in vivo activity against dengue and other flaviviruses," can be accessed here. The published data demonstrate that AT-752 has potent in vitro activity against multiple dengue virus serotypes and other flaviviruses tested, and reduces viremia and improves survival in an animal model of dengue disease. 

    "Affecting over 100 countries, dengue fever is endemic and has quickly become the most prevalent mosquito-borne viral disease globally with incidence continuing to rise. Therapeutics to treat and prevent this debilitating and life-threatening disease are urgently needed. An oral, easily administered, direct-acting antiviral that can treat infections caused by the multiple serotypes of the dengue virus would be a significant advance," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "The encouraging in vitro and in vivo data published in this peer-reviewed journal strongly support clinical development to evaluate AT-752 for the potential treatment and prophylaxis of dengue fever."

    AT-752, an oral direct-acting antiviral, targets the non-structural protein 5 (NS5) polymerase of dengue virus. The highly conserved nature of the dengue viral polymerase potentially allows for a single, selective agent, such as AT-752 to be active against all dengue serotypes. Additionally, the structure of AT-752, a double prodrug nucleotide analog, has been uniquely designed to enhance oral bioavailability and delivery of the active triphosphate to target tissues while providing a favorable safety profile.

    Atea recently completed the single ascending dose (SAD) portion of a Phase 1a clinical trial of AT-752 and the multiple ascending dose portion is currently underway. Data from the SAD portion of the Phase 1a trial demonstrated that AT-752 was well tolerated (no serious adverse events or drug-related discontinuations) with mostly dose-proportional pharmacokinetics up to 1500 mg, the highest single oral dose tested. The Phase 1a trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and pharmacokinetics of AT-752 in healthy volunteers. The study is expected to enroll up to 60 subjects and is designed to support dose selection for future clinical studies of AT-752 as a potential treatment and prophylaxis for dengue fever.

    About Dengue Fever

    Dengue virus is part of a family of single-stranded, positive-sense RNA viruses known as flaviviruses. These mosquito and tick-borne viruses can infect humans and are responsible for widespread morbidity and mortality worldwide, according to the United States Centers for Disease Control and Prevention (CDC).

    Dengue virus is the most prevalent flavivirus, according to the CDC, with an estimated 400 million infections each year resulting in 100 million clinical manifestations including dengue hemorrhagic fever, or severe dengue, and approximately 25,000 deaths. In the last 20 years, there was an 8-fold increase of dengue cases reported to the World Health Organization (WHO). Large outbreaks, while occurring mostly in tropical and sub-tropical regions of the world including Africa, Southeast Asia and South America, have also occurred in parts of Europe, and dengue is now endemic in more than 100 countries/regions worldwide including the U.S. territories of Puerto Rico, the U.S. Virgin Islands and American Samoa. Dengue fever is also on the rise in the continental United States with over 5,000 cases, mostly travel-associated, reported between 2010 and 2017.

    There are four antigenically distinct but closely related dengue virus serotypes (DENV1-4). Isolation of a fifth serotype (DENV-5) was reported in 2015 but has yet to be officially recognized. According to the WHO, recovery from infection is believed to provide lifelong immunity against the specific serotype that caused the infection. However, cross-immunity to other serotypes after recovery is only partial and transient. Furthermore, subsequent infection by other serotypes increases the risk of developing severe dengue through a process known as antibody-dependent enhancement (ADE), which, in turn, increases the risk of death.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidate, AT-752. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our reported preclinical and initial phase 1 results of AT-752 to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements including future results from subsequent clinical studies of AT-752 and our ability to successfully develop AT-752 as a treatment for dengue. These and other important factors discussed under the caption "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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    • New Data in Healthy Volunteers Confirmed that AT-527's Active Metabolite Achieved Target Antiviral Levels in Lungs, Key Site of COVID-19 Infection

    • AT-527 Phase 2 Study Interim Results Showed Potent and Rapid Antiviral Activity in Hospitalized Patients; Study to Advance with Protocol Amendments Reflecting Evolving COVID-19 Environment

    • Accruing Patients in Global Phase 3 MEADOWSPRING Follow-on Study to Evaluate AT-527 in Long COVID

    • Global Phase 2 MOONSONG Results and Global Phase 3 MORNINGSKY Results Expected in 2H 2021

    • Conference Call at 4:30 p.m. ET Today

    BOSTON, Mass., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today reported financial results for the second…

    • New Data in Healthy Volunteers Confirmed that AT-527's Active Metabolite Achieved Target Antiviral Levels in Lungs, Key Site of COVID-19 Infection



    • AT-527 Phase 2 Study Interim Results Showed Potent and Rapid Antiviral Activity in Hospitalized Patients; Study to Advance with Protocol Amendments Reflecting Evolving COVID-19 Environment



    • Accruing Patients in Global Phase 3 MEADOWSPRING Follow-on Study to Evaluate AT-527 in Long COVID



    • Global Phase 2 MOONSONG Results and Global Phase 3 MORNINGSKY Results Expected in 2H 2021



    • Conference Call at 4:30 p.m. ET Today

    BOSTON, Mass., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today reported financial results for the second quarter ended June 30, 2021 and provided a clinical and corporate update.

    "We are very encouraged by new data, reported for the first time, that an investigational, direct-acting antiviral for COVID-19 achieved target drug levels in the lungs. In healthy volunteers, AT-527's active metabolite achieved target antiviral levels in lining fluid of the lungs, where SARS-CoV-2 virus replicates. These data not only provide further confidence for treatment but also support development of AT-527 for prophylaxis of COVID-19 and build upon our recent Phase 2 interim results showing treatment with AT-527 resulted in a rapid decline in viral load, which led to viral clearance. Impacting key sites of infection will be important in helping patients recover faster while minimizing virus transmission," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. 

    "As COVID-19 becomes endemic and continues to evolve with the highly transmissible Delta variant and other variants, we need a multi-pronged treatment approach including safe and effective oral antiviral options that may play an important role in helping to reduce the global burden of disease," said Janet Hammond, MD, PhD, Chief Development Officer of Atea Pharmaceuticals. "We are very pleased with our results showing AT-527's strong antiviral potential and we continue to advance multiple global clinical studies in parallel with our collaborator Roche, to provide further clinical evidence in support of AT-527 as an oral, potent, direct-acting antiviral treatment for COVID-19."

    Recent AT-527 Clinical Development Highlights

    Drug Levels in Lung Lining Fluid in Healthy Volunteers: First investigational direct-acting antiviral (DAA) being developed for COVID-19 to report target antiviral levels in lungs, primary site of infection for the virus

    • New results from a bronchoalveolar lavage (BAL) study in healthy volunteers showed AT-527's active metabolite achieved target antiviral levels in the lungs, where the SARS-Cov-2 virus replicates. The data show that target drug levels were achieved with AT-527 550 mg twice-daily (BID) dosing regimen leading to plasma and intrapulmonary (epithelial lining fluid, ELF) levels of AT-273 (surrogate of the active triphosphate metabolite) exceeding the target concentration.

    New Preclinical and Clinical Results: Expanding AT-527's favorable profile

    • Analysis of SARS-CoV-2 infected cells treated with AT-511 (the free base of AT-527) by next generation sequencing (NGS) confirmed that AT-527 is not a mutagen and does not introduce mutations in the viral genome.



    • A new drug-drug interaction study in healthy volunteers indicated that no AT-527 dose adjustment should be necessary when co-administered with drugs that are CYP3A substrates as AT-527 is a weak inhibitor of CYP3A.

    Global Phase 2 Trial of AT-527 in Hospitalized Setting: Positive interim virology results demonstrated rapid and sustained viral load decrease and viral clearance

    • In June 2021, Atea announced a Phase 2 interim virology analysis of AT-527 550 mg BID dosing, which demonstrated a rapid reduction in viral load levels. The results included data from 70 hospitalized, high-risk patients with COVID-19 of which data from 62 patients were evaluable for virology analysis. At Day 2, patients receiving AT-527 experienced a 0.7 log10 (80%) greater mean reduction from baseline viral load versus placebo.



    • AT-527's SARS-CoV-2 potent antiviral activity was also observed in patients with baseline viral loads above the median of 5.26 log10 as compared to placebo. The results showed that viral clearance of SARS-CoV-2 RNA in patients with higher baseline viral load (≥ median) was faster in patients treated with AT-527 versus placebo.



    • Consistent with previous studies, AT-527 was generally safe and well tolerated. These interim results will be submitted for presentation at scientific meetings and to peer-reviewed publications. To access the press release reporting these results, click here.

    Protocol Amendment for Global Phase 2 Study in Hospitalized Setting: Reflecting evolving COVID-19 environment

    • The global Phase 2 study in the hospitalized setting is being amended with protocol changes emanating from the evolving COVID-19 environment which is reflected in the current standard of care and currently measurable study endpoints. The protocol amendments include changing the primary endpoint to virology, adding a Part B cohort comprised of up to 110 patients and exploring alternative doses.

    Global Phase 2 MOONSONG Trial of AT-527 in Outpatient Setting: Study ongoing with interim virology data expected in 2H 2021

    • Patient enrollment continues in the Phase 2 MOONSONG trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial, which is being conducted in collaboration with Roche, may enroll up to 220 patients in multiple countries. The randomized, double-blind, multi-center, placebo-controlled trial is evaluating the antiviral activity, safety and pharmacokinetics of AT-527 550 mg, and other doses, administered BID in adult patients with mild or moderate COVID-19. The primary endpoint of this trial is change from baseline in amount of SARS-CoV-2 virus RNA as measured by reverse transcription polymerase chain reaction (RT-PCR) at specified timepoints.

    Global Phase 3 MORNINGSKY Registrational Trial of AT-527 in Outpatient Setting: Recruitment ongoing with results anticipated in 2H 2021

    • The global Phase 3 MORNINGSKY registrational clinical trial, being conducted in collaboration with Roche, is designed to enroll up to 1,400 patients globally. The randomized, double-blind, multi-center, placebo-controlled Phase 3 trial is evaluating the antiviral activity, safety and pharmacokinetics of AT-527 550 mg administered BID in adult patients with COVID-19 in an outpatient setting. The primary endpoint of this trial is time to alleviation or improvement of COVID-19 symptoms maintained for 24 hours.

    Global Phase 3 Follow-on MEADOWSPRING Initiated: Long-term study to understand the impact of AT-527 treatment on long COVID

    • MEADOWSPRING, a six-month long-term follow-on study conducted in collaboration with Roche, was recently initiated to evaluate the impact of prior administration of AT-527 on long COVID in patients previously enrolled in MORNINGSKY. This non-interventional study is expected to enroll approximately 1,000 patients and is currently accruing patients.

    Recent AT-752 Clinical Development Highlights

    Phase 1a Trial of AT-752 for Dengue Fever: Completed single ascending dose portion and initiated multiple ascending dose portion

    • The Phase 1a single ascending dose study portion of the trial evaluating multiple doses has been successfully completed. The multiple-ascending dose portion of the trial was initiated during Q3 2021. The Phase 1a trial is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and pharmacokinetics of AT-752 in healthy volunteers. The study is expected to enroll up to 60 subjects.

    Recent Corporate Highlights

    $50 Million Development Milestone Achieved Under License Agreement with Roche

    • In June 2021, Atea announced the achievement of a milestone associated with the development of AT-527, and in July 2021, received a $50 million payment under its license agreement with Roche. Under the license agreement, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19. Atea retains rights to commercialize AT-527 in the United States and Roche has the exclusive right to commercialize AT-527 outside of the United States. 

    Appointment of Jerome Adams, M.D., M.P.H., to Board of Directors

    • In May 2021, Atea announced the appointment of Jerome Adams, M.D., M.P.H., to its Board of Directors. Dr. Adams most recently served as Surgeon General of the United States and brings a wide range of experience spanning clinical practice, clinical research, public health and government agency leadership.

    Senior Management Appointment

    • In June 2021, the Company announced the appointment of Claudio Avila, MB, BS, Ph.D., as Senior Vice President of Medical Affairs. Dr. Avila previously served as Executive Director, U.S. Medical Strategy and Medical Affairs for COVID-19 at Gilead Sciences.

    Second Quarter 2021 Financial Results

    Cash and Cash Equivalents: $816.5 million at June 30, 2021 compared to $850.1 million at December 31, 2020. The cash balance at June 30, 2021 does not include the $50 million milestone payment realized under the license agreement Atea entered into with F. Hoffmann-La Roche Ltd. and Genentech, Inc. in October 2020 ("Roche License Agreement"), which was received in July 2021.

    Revenue: Collaboration revenue for the quarter ended June 30, 2021 in the amount of $60.4 million increased by $60.4 million from $0 million for the quarter ended June 30, 2020. All collaboration revenue was derived from the Roche License Agreement which was entered into in October 2020. 

    Research and Development Expenses: Research and development expenses for the quarter ended June 30, 2021 in the amount of $39.8 million increased by $32.0 million from $7.8 million for the quarter ended June 30, 2020. The increase in research and development expenses was primarily due to an increase in external expenses incurred related to the CRO and CMO services in conjunction with the advancement of product candidates for the treatment of COVID-19 and dengue fever, including our share of costs incurred by Roche, and increases in internal spend primarily due to an increase in personnel-related expenses, including salaries, benefits and stock-based compensation expense for our research and product development employees and consulting fees and other research and development expenses.

    General and Administrative Expenses: General and administrative expenses for the quarter ended June 30, 2021 in the amount of $11.9 million increased by $9.7 million from $2.2 million for the quarter ended June 30, 2020. The increase in general and administrative expenses was primarily due to the expansion of our organization and reflected an increase in payroll and personnel-related expenses, including salaries, benefits and stock-based compensation expense and other general and administrative expenses.

    Income Tax Expense: Income tax expense for the quarter ended June 30, 2021 in the amount of $7.2 million increased by $7.2 million from $0 million for the three months ended June 30, 2020. The increase in income tax expense was primarily due to realization of income as a result of the recognition of revenue in 2021 associated with the Roche License Agreement. The tax provision was calculated based on the year-to-date effective rate.

    Net Income (loss): Net income for the quarter ended June 30, 2021 in the amount of $1.5 million increased by $11.5 million from a net loss of $10.0 million for the quarter ended June 30, 2020.

    Selected Condensed Consolidated Balance Sheets

    (in thousands, except share and per share amounts)

    (Unaudited)
      June 30, 2021  December 31, 2020
    Cash and cash equivalents $816,460  $850,117
            
    Accounts receivable  50,000   ---
            
    Total assets  871,543   863,632
            
    Total liabilities  273,682   315,831
            
    Total stockholders' equity  597,861   547,801



    Condensed Consolidated Statement of Operations and Comprehensive Income

    (in thousands, except share and per share data)

    (Unaudited)
      Three Months Ended June 30, Six Months Ended June 30,
      2021 2020 2021 2020
    Collaboration revenue $60,391  $---  $126,376  $ 
    Operating expenses        
    Research and development  39,803   7,755   66,375   10,576 
    General and administrative  11,901   2,248   20,658   3,472 
    Total operating expenses  51,704   10,003   87,033   14,048 
    Income (loss) from operations  8,687   (10,003)  39,343   (14,048)
    Interest income and other, net  52   10   109   67 
    Income (loss) before income taxes  8,739  $(9,993) $39,452  $(13,981)
    Income tax expense  (7,200)  ---   (7,200)  --- 
    Net Income (loss) and comprehensive income (loss) $1,539  $(9,993) $32,252  $(13,981)
             
    Net income (loss) per share

    attributable to common stockholders
              
    Basic $0.02  $(0.99) $0.39  $(1.39)
    Diluted $0.02  $(0.99) $0.36  $(1.39)
    Weighted-average shares outstanding          
    Basic  82,743,530   10,096,307   82,662,019   10,093,689 
    Diluted  88,091,384   10,096,307   88,683,767   10,093,689 

    Conference Call and Webcast

    Atea will host a conference call and live audio webcast to discuss the second quarter 2021 financial results and provide a corporate update today at 4:30 p.m. ET. To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time and refer to conference ID 5795073.

    A live audio webcast of the call and accompanying slide presentation will also be available in the Investors' Events & Presentations section of the Company's website, www.ateapharma.com. An archived webcast will be available on the Atea website approximately two hours after the event.

    About the AT-527 COVID-19 Clinical Development Program

    AT-527 is an oral direct-acting antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is being evaluated in the global Phase 3 MORNINGSKY trial, a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 MOONSONG virology study in patients with mild or moderate COVID-19 in an outpatient setting. In addition, MEADOWSPRING, a Phase 3 long-term follow-on study, will evaluate the impact of prior administration of AT-527 in long COVID.

    A direct-acting antiviral aims to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it well suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, AT-527, and expectations regarding our pipeline, including trial design and development timelines. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process and reliance on interim or topline clinical trial results; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  2. BOSTON, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it will host a live conference call and audio webcast on Thursday, August 12, 2021 at 4:30 p.m. ET to report financial results for the second quarter ended June 30, 2021, and to provide a clinical and corporate update.

    To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time, and refer to conference ID 5795073. A live audio webcast of the call and accompanying slide presentation will be available in the Investors' Events & Presentations section of the Company's website, www.ateapharma.com

    BOSTON, Aug. 05, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it will host a live conference call and audio webcast on Thursday, August 12, 2021 at 4:30 p.m. ET to report financial results for the second quarter ended June 30, 2021, and to provide a clinical and corporate update.

    To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time, and refer to conference ID 5795073. A live audio webcast of the call and accompanying slide presentation will be available in the Investors' Events & Presentations section of the Company's website, www.ateapharma.com. An archived webcast will be available on the Atea website approximately two hours after the event.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapeutics to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  3. BOSTON, July 12, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced that Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea together with other members of the Atea management team, will participate in a fireside chat at the William Blair Biotech Focus Conference on Thursday, July 15, 2021 at 12:00 p.m. ET.

    A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals…

    BOSTON, July 12, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced that Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea together with other members of the Atea management team, will participate in a fireside chat at the William Blair Biotech Focus Conference on Thursday, July 15, 2021 at 12:00 p.m. ET.

    A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapeutics to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  4. Phase 2 Interim Virology Results Indicate Rapid and Sustained Antiviral Activity Against SARS-CoV-2 in Patients with COVID-19 in the Hospitalized Setting

    AT-527 is Being Studied in Multiple Clinical Studies, Including Global Phase 2 MOONSONG and Phase 3 MORNINGSKY Trials, with Results Expected During 2H 2021

    BOSTON, Mass., June 30, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced positive interim results from the global Phase 2 study evaluating AT-527 in hospitalized patients with mild-to-moderate COVID-19. Roche and Atea are jointly developing AT-527, an oral direct-acting antiviral (DAA…

    Phase 2 Interim Virology Results Indicate Rapid and Sustained Antiviral Activity Against SARS-CoV-2 in Patients with COVID-19 in the Hospitalized Setting

    AT-527 is Being Studied in Multiple Clinical Studies, Including Global Phase 2 MOONSONG and Phase 3 MORNINGSKY Trials, with Results Expected During 2H 2021

    BOSTON, Mass., June 30, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced positive interim results from the global Phase 2 study evaluating AT-527 in hospitalized patients with mild-to-moderate COVID-19. Roche and Atea are jointly developing AT-527, an oral direct-acting antiviral (DAA) agent derived from Atea's purine nucleotide prodrug platform.

    The interim analysis of the Phase 2 study included data from 70 hospitalized, high-risk patients with COVID-19 of which data from 62 patients were evaluable for virology analysis. Interim virology results indicated that AT-527 rapidly reduced viral load levels. At Day 2, patients receiving AT-527 experienced a 0.7 log10 (80%) greater mean reduction from baseline viral load as compared to placebo. A sustained difference in viral load reduction was maintained through Day 8.

    AT-527's SARS-CoV-2 potent antiviral activity was also observed in patients with higher baseline viral loads above the median of 5.26 log10 as compared to placebo. When evaluating a strict RT-qPCR threshold of 500 copies/mL with no detectable ribonucleic acid (RNA) virus (target not detected, TND), the AT-527 arm achieved SARS-CoV-2 clearance as early as Day 2 (in 6% of patients), Day 8 (in 7% of patients) Day 10 (in 33% of patients), and Day 12 (in 31% of patients) compared to 0% of patients in the placebo arm at the same timepoints. By Day 14 (last viral sampling study day) approximately 47% of patients in the AT-527 arm and 22% in the placebo arm had no detectable RNA virus (TND). Nasopharyngeal swabs were measured in a reverse transcription polymerase chain reaction test (RT-qPCR) for the quantitative detection of nucleic acid from SARS-CoV-2.

    Consistent with previous studies, AT-527 was generally safe and well tolerated. In this hospitalized study, there were no drug-related serious adverse events. Non-serious adverse events were equally distributed across treatment arms. Most were mild-to-moderate in severity and assessed as not related to the study drug. No safety concerns or newly determined risks were identified.

    "We are very pleased with the potent antiviral activity of AT-527 demonstrated by the rapid inhibition of SARS-CoV-2 replication. Such potent activity may lead to faster recovery time for patients with COVID-19 while minimizing the transmission of infection," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "As COVID-19 continues to evolve worldwide, we need a multi-pronged approach to control this disease. AT-527, an oral, potent, target-specific DAA, may offer a convenient treatment to prevent disease progression and allow people to resume daily life more quickly, especially in areas where vaccines and antibody therapies are not readily available."

    "The safety and tolerability profile for AT-527 continues to provide us with confidence that it has the potential to be used in hospitalized and outpatient settings for treatment and prophylaxis, which should significantly alleviate the burden on healthcare systems," said Janet Hammond, MD, PhD, Chief Development Officer of Atea. "As we continue to advance our clinical development program, we look forward to sharing further results and analyses, including reporting results from the Phase 2 MOONSONG virology study in the outpatient setting. This multi-cohort data from MOONSONG, which we expect in the third quarter, will further inform AT-527 dosing regimens in various clinical settings."

    Final data from the full Phase 2 program will be submitted to an upcoming medical congress or a peer-reviewed publication.

    About the Global Phase 2 Study of AT-527 in the Hospitalized Setting

    The global Phase 2 trial in the hospital setting is a randomized, double-blind, placebo-controlled, multi-center study to evaluate AT-527 in patients with moderate COVID-19. Study objectives are to assess safety, tolerability, clinical and antiviral efficacy. Patients were randomized ≤ 5 days of symptom onset to receive either AT-527 550 mg twice-daily (BID) or placebo BID dosed for 5 days. The key inclusion criteria for this study were adult patients ≥ 18 years old with risk factors such as obesity, diabetes and hypertension.

    Results from this Phase 2 study in hospitalized patients included pre-specified, interim virology data. This Phase 2 study was designed to gain confidence around the safety and tolerability of AT-527 and was not powered to show definitive clinical outcomes, which are being evaluated in the global Phase 3 MORNINGSKY trial.

    The evaluation of infectious virus (viable virus able to replicate in cell culture) was an exploratory endpoint in this study and the current standard assay used was not able to measure the infectious virus in > 95% of the nasopharyngeal samples.

    AT-527 Preclinical Update

    Data from recently completed preclinical studies demonstrated that AT-527 inhibits SARS-CoV-2 through unique dual mechanisms targeting both RNA dependent RNA polymerase (RdRP) and the nidovirus RdRp-associated nucleotidyltransferase (NiRAN) of viral non-structural protein (nsp12) polymerase, which is essential for viral RNA replication and transcription. In addition, analysis of samples treated with AT-511 (the free base of AT-527) by next generation sequencing (NGS) confirmed that AT-527 is not a mutagen and does not introduce mutations in the viral genome. These data will be submitted for peer-reviewed publication.

    About the AT-527 COVID-19 Clinical Development Program

    AT-527 is an oral direct-acting antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is being evaluated in the global Phase 3 MORNINGSKY trial, a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 MOONSONG virology study in patients with mild or moderate COVID-19 in an outpatient setting.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, in particular AT-527, and expectations regarding our pipeline. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  5. BOSTON, June 16, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced that it has achieved a milestone associated with the development of AT-527 and expects to receive a related payment under its license agreement with Roche of $50 million ((SIX: RO, ROG, OTCQX:RHHBY). Under the license agreement, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19. Atea retains rights to commercialize AT-527 in the United States and Roche has the exclusive right to commercialize AT-527 outside of the United States. AT-527 is an orally administered, direct-acting…

    BOSTON, June 16, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced that it has achieved a milestone associated with the development of AT-527 and expects to receive a related payment under its license agreement with Roche of $50 million ((SIX: RO, ROG, OTCQX:RHHBY). Under the license agreement, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19. Atea retains rights to commercialize AT-527 in the United States and Roche has the exclusive right to commercialize AT-527 outside of the United States. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform and is in Phase 3 development for the treatment of COVID-19.

    "Working closely with our strategic collaborator Roche, this achievement is reflective of the continual rapid advancement of the AT-527 program," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "The realization of this milestone brings us one step closer to our goal of providing an easily administered oral, direct-acting antiviral in the fight against this global pandemic."

    Direct-acting antivirals, such as AT-527, aim to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. Atea believes this makes AT-527 well-suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

    About the AT-527 COVID-19 Clinical Development Program

    AT-527 is an orally administered, direct-acting antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in the global Phase 3 MORNINGSKY trial, a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 outpatient study in patients with mild or moderate COVID-19.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our AT-527 product candidate and expectations regarding payments under our license agreement with Roche. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  6. BOSTON, June 15, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced the appointment of Claudio Avila, MB, BS, Ph.D., as Senior Vice President of Medical Affairs. Dr. Avila previously served as Executive Director, U.S. Medical Strategy and Medical Affairs for COVID-19 at Gilead Sciences.

    "We are very pleased to welcome Claudio to the Atea team. Claudio's extensive expertise and experience in medical affairs with a focus on COVID-19, hepatitis and HIV as part of his overall interest in serious viral infectious diseases, will complement and strengthen the capabilities of Atea," said Jean-Pierre…

    BOSTON, June 15, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced the appointment of Claudio Avila, MB, BS, Ph.D., as Senior Vice President of Medical Affairs. Dr. Avila previously served as Executive Director, U.S. Medical Strategy and Medical Affairs for COVID-19 at Gilead Sciences.

    "We are very pleased to welcome Claudio to the Atea team. Claudio's extensive expertise and experience in medical affairs with a focus on COVID-19, hepatitis and HIV as part of his overall interest in serious viral infectious diseases, will complement and strengthen the capabilities of Atea," said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. "As we continue to advance our late-stage antiviral pipeline, including AT-527 for the treatment of COVID-19, we look forward to integrating Claudio's broad international medical affairs experience in our efforts to bring new drugs to the market."

    "I am delighted to join Atea at such an exciting time and to contribute to its goal of bringing an easily administered oral antiviral to help in the fight against the COVID-19 pandemic," said Dr. Avila. "In addition, I am looking forward to helping build Atea into a global leader in the discovery and development of oral direct-acting antivirals for the treatment of severe viral diseases."

    Dr. Avila joins Atea from Gilead Sciences, where he served in roles of increasing responsibility, most recently as Executive Director, U.S. Medical Strategy and Medical Affairs for COVID-19. Prior roles at Gilead Sciences included Medical Affairs leadership of the Asia Pacific region, including Japan and China; and for HCV in Europe, the Middle East and Australia. Earlier in his career, Dr. Avila was a Global Program Medical Director for Hepatitis B and C development at Novartis Pharma AG and his first industry role was as Medical Advisor in HIV at GlaxoSmithKline (UK). Dr. Avila's medical career was as honorary infectious diseases physician in the United Kingdom and medical officer in Australia.

    Dr. Avila received his medical degree (MB, BS) from Sydney University and BSc (Hons) / Ph.D. from Melbourne University. He has authored more than three dozen peer-reviewed publications.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, in particular AT-527, and expectations regarding our pipeline. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  7. BOSTON, May 26, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced that Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea will present a corporate overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:30 p.m. ET.

    A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.  

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused…

    BOSTON, May 26, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral therapeutics for severe viral infections, today announced that Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea will present a corporate overview at the Jefferies Virtual Healthcare Conference on Wednesday, June 2, 2021 at 2:30 p.m. ET.

    A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.  

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  8. BOSTON, May 20, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next-generation therapeutics for severe viral infections, today announced the appointment of Jerome Adams, M.D., M.P.H., to its Board of Directors. Dr. Adams most recently served as Surgeon General of the United States and brings a wide range of experience spanning clinical practice, clinical research, public health, and government agency leadership.

    "We are honored to welcome Dr. Adams to our Board of Directors, as his unique experience as Surgeon General during the COVID-19 pandemic will undoubtedly help guide Atea as we continue to advance our antiviral pipeline, including our global Phase 3 MORNINGSKY…

    BOSTON, May 20, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next-generation therapeutics for severe viral infections, today announced the appointment of Jerome Adams, M.D., M.P.H., to its Board of Directors. Dr. Adams most recently served as Surgeon General of the United States and brings a wide range of experience spanning clinical practice, clinical research, public health, and government agency leadership.

    "We are honored to welcome Dr. Adams to our Board of Directors, as his unique experience as Surgeon General during the COVID-19 pandemic will undoubtedly help guide Atea as we continue to advance our antiviral pipeline, including our global Phase 3 MORNINGSKY trial of AT-527 for the treatment of COVID-19," said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals.

    "As a result of the COVID-19 pandemic, the focus of citizens and governments throughout the world on public health and infectious diseases is extremely high. With AT-527, Atea has the potential to bring an easily administered oral antiviral to help in the fight against this global public health crisis. I am looking forward to lending my expertise to help advance this important program, while also supporting Atea in the development of its broader antiviral pipeline for severe viral diseases," commented Dr. Adams.

    Dr. Adams served as the 20th Surgeon General of the United States from 2017 to 2021, where he focused on the opioid epidemic and was a member of the COVID-19 Task Force. Prior to that, he served as the State Health Commissioner for Indiana from 2014 to 2017, where he presided over Indiana's efforts to deal with state-wide, unprecedented HIV outbreak. Before beginning his public service in 2014, Dr. Adams was a practicing anesthesiologist and Associate Professor in the Department of Anesthesiology at Indiana University. Earlier in his career, Dr. Adams was a Clinical Research Assistant at Eli Lilly and Company. He has served in leadership positions at a number of professional organizations, including the American Medical Association, the Indiana State Medical Association, and the Indiana Society of Anesthesiologists.

    Dr. Adams received a B.S. in Biochemistry and B.A. in Psychology from the University of Maryland and holds an M.P.H. from the University of California, Berkeley, and an M.D. from Indiana University School of Medicine.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, in particular AT-527, and expectations regarding our pipeline. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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    • Global Phase 3 MORNINGSKY trial of AT-527 in the outpatient setting recently initiated for the treatment of COVID-19

    • Enrollment advancing in Phase 1a trial of AT-752; drug candidate being developed for the treatment of dengue fever

    BOSTON, May 13, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today reported financial results for the quarter ended March 31, 2021 and provided a corporate update.

    "Over the course of a year, we have gone from filing an Investigational New Drug Application for AT-527, an oral direct-acting antiviral for the treatment of COVID-19, to the recent initiation of a global Phase 3 trial in the outpatient setting. Working closely with our strategic…

    • Global Phase 3 MORNINGSKY trial of AT-527 in the outpatient setting recently initiated for the treatment of COVID-19



    • Enrollment advancing in Phase 1a trial of AT-752; drug candidate being developed for the treatment of dengue fever

    BOSTON, May 13, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today reported financial results for the quarter ended March 31, 2021 and provided a corporate update.

    "Over the course of a year, we have gone from filing an Investigational New Drug Application for AT-527, an oral direct-acting antiviral for the treatment of COVID-19, to the recent initiation of a global Phase 3 trial in the outpatient setting. Working closely with our strategic partner Roche, this significant milestone represents a major advancement toward our goal of providing an easily administered and widely available oral antiviral to help in the fight against this global pandemic," said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals.

    "In addition to the important work we are doing in COVID-19, we are utilizing the power of our proprietary nucleotide prodrug platform in other infectious diseases. Toward that end, we are very pleased to have initiated our Phase 1a study evaluating the safety, tolerability, and pharmacokinetics of AT-752. We look forward to reporting data from this study in the second half of 2021 and to furthering the development of this novel compound as an oral treatment for dengue fever, which the World Health Organization has called the most important mosquito borne viral disease in the world," continued Dr. Sommadossi.

    AT-527 for the Treatment of COVID-19

    Global Phase 3 MORNINGSKY Trial of AT-527 in the Outpatient Setting

    • In April 2021, Atea announced the first patient dosed in a global Phase 3 MORNINGSKY trial evaluating AT-527 in the outpatient setting for the treatment of COVID-19. The trial, which is being conducted in collaboration with Roche, is anticipated to enroll up to 1,400 patients globally. The randomized, double-blind, multi-center, placebo-controlled, outpatient Phase 3 trial will evaluate the efficacy, safety, pharmacokinetics, and antiviral activity of AT-527 in adult and adolescent patients with mild to moderate COVID-19. The primary endpoint, evaluating the efficacy of AT-527 compared with placebo, will measure the time to alleviation or improvement of COVID-19 symptoms.

    Phase 2 Trial of AT-527 in the Outpatient Setting

    • In February 2021, Atea announced the first patient dosed in a Phase 2 clinical trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial, which is being conducted in collaboration with Roche, is anticipated to enroll up to 220 patients globally. The randomized, double-blind, multi-center, placebo-controlled Phase 2 trial will evaluate the antiviral activity, safety, and pharmacokinetics of AT-527 in adult patients with mild or moderate COVID-19 in the outpatient setting. The primary endpoint of this trial is change from baseline in amount of SARS-CoV-2 virus RNA as measured by reverse transcription polymerase chain reaction (RT-PCR) at specified timepoints.

    Phase 2 Trial of AT-527 in the Hospitalized Setting

    • The ongoing Phase 2 trial in the hospitalized setting is a randomized, double-blind, placebo-controlled, multi-center, global trial of AT-527. This trial is anticipated to enroll approximately 190 hospitalized patients with moderate COVID-19. The primary efficacy endpoint of this trial is the change in level of respiratory insufficiency, and other assessments will include viral kinetics and safety and tolerability of AT-527 at the dose of 550 mg administered twice-daily.

    Presentation of AT-527 Phase 1 Results at CROI

    • In March 2021, Atea presented favorable results from a Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI). The results showed AT-527 was well tolerated with no discontinuations or serious adverse events and no clinically significant changes in vital signs or electrocardiograms were observed. The data also demonstrated that AT-511 (the free base of AT-527) was rapidly absorbed followed by fast and extensive stepwise metabolic activation to the active triphosphate AT-9010, reflected by plasma AT-273. Steady state levels were quickly achieved by the third dose of AT-527. The Phase 1 study results validate the modeling from our preclinical animal models which predict that lung levels should be consistently above the EC90 level of 0.5 uM. Since the respiratory tract is the initiation site of the SARS-CoV-2 replication, these data demonstrate the potential for AT-527 to achieve meaningful drug levels in the lungs.

    Overview of AT-527 at ICAR

    • In March 2021, at the invitation of the organizers of the 34th International Conference on Antiviral Research (ICAR), Atea presented an overview of AT-527, including the Phase 1 results as well as preclinical data and the underlying mechanistic rationale supporting the use of AT-527 for the treatment of COVID-19.

    Publication of Preclinical Data Highlighting Potency of AT-527 Against SARS-CoV-2

    • In February 2021, Atea announced the publication of new data showcasing the highly potent in vitro antiviral activity of AT-527 against SARS-CoV-2. The new findings were made available in a manuscript published online in Antimicrobial Agents and Chemotherapy. These data underscore key mechanistic features enabling AT-527 to inhibit SARS-CoV-2 viral replication and support AT-527's clinical development program.

    AT-527 Japan Rights

    • In February 2021, Atea announced that Chugai Pharmaceutical Co., Ltd. (TYO:4519) in-licensed from Roche the rights to develop and market AT-527 for the treatment of COVID-19 in Japan. The recently initiated global Phase 3 trial evaluating AT-527 in the outpatient setting in adults and adolescent patients with mild to moderate COVID-19 is expected to include patients in Japan.

    AT-752 for the Treatment of Dengue Fever

    AT-752 Phase 1a Trial

    • In March 2021, Atea initiated a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1a study that will evaluate the safety, tolerability, and pharmacokinetics of AT-752 in healthy subjects. The Phase 1a study is expected to enroll up to 60 subjects in Australia. The objective of the study is to establish the safety and tolerability of AT-752 and also to support dose selection for future studies of AT-752 as a treatment for dengue fever.

    First Quarter 2021 Financial Results

    Cash and Cash Equivalents: $833.8 million at March 31, 2021 compared to $850.1 million at December 31, 2020.

    RevenueCollaboration revenue for the quarter ended March 31, 2021 in the amount of $66.0 million was derived from the license agreement Atea entered into with F. Hoffmann-La Roche Ltd. and Genentech, Inc. in October 2020 ("Roche License Agreement"). All amounts recognized as revenue during the quarter ended March 31, 2021 were included in deferred revenue at December 31, 2020.

    Research and Development Expenses: Research and development expenses for the quarter ended March 31, 2021 in the amount of $26.6 million increased by $23.8 million from $2.8 million for the quarter ended March 31, 2020. The increase in research and development expenses was primarily due to an increase in external expenses incurred related to the CRO and CMO services in conjunction with the advancement of product candidates for the treatment of COVID-19 and dengue fever, including our share of costs incurred by Roche, and increases in internal spend primarily due to an increase in personnel-related expenses, including salaries and bonuses, benefits and stock-based compensation expense for our research and product development employees and consulting fees and other research and development expenses.

    General and Administrative Expenses: General and administrative expenses for the quarter ended March 31, 2021 in the amount of $8.8 million increased by $7.6 million from $1.2 million for the quarter ended March 31, 2020. The increase in general and administrative expenses was primarily due to the expansion of our organization and reflected an increase in payroll and personnel-related expenses, including salaries, benefits and stock-based compensation expense and other general and administrative expenses.

    Net income (loss): Net income for the quarter ended March 31, 2021 in the amount of $30.7 million increased by $34.7 million from a net loss of $4.0 million for the quarter ended March 31, 2020. The net income for the quarter ended March 31, 2021 resulted principally from the recognition of collaboration revenue related to the Roche License Agreement in the amount of $66.0 million, partially offset by the increases in research and development expenses and general and administrative expenses described above.



    Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)

    (in thousands, except share and per share amounts)

    (Unaudited)
     Three Months Ended March 31,
      2021  2020 
        
    Collaboration revenue$65,985 $ 
    Operating expenses   
    Research and development 26,571  2,821 
    General and administrative 8,759  1,224 
    Total operating expenses 35,330  4,045 
    Income (loss) from operations 30,655  (4,045)
    Interest income and other, net 58  57 
    Net income (loss) and comprehensive income (loss)$30,713 $(3,988)
    Net income (loss) per share attributable to common stockholders   
    Basic$0.37 $(0.40)
    Diluted$0.34 $(0.40)
    Weighted-average common shares outstanding   
    Basic 82,577,836  10,091,000 
    Diluted 89,099,075  10,091,000 



     
    Selected Consolidated Balance Sheet Data

    (in thousands)
     March 31, 2021 December 31, 2020
    Assets   
    Cash and cash equivalents$833,751 $850,117
    Working capital (1) $585,867 $547,682
    Total assets$840,649 $863,632
    Deferred revenue$235,382 $301,367
    Total stockholders' equity$586,258 $547,801
    (1) The Company defines working capital as current assets less current liabilities. See the Company's condensed consolidated financial statements in its Quarterly Report on Form 10-Q for the three months ended March 31, 2021 for further detail regarding its current assets and liabilities.
     

    Conference Call and Webcast Information

    Atea will host a conference call and live audio webcast to discuss the first quarter 2021 financial results and provide a corporate update today at 4:30 p.m. ET. To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time and refer to conference ID 8609279.

    A live audio webcast of the call and accompanying slide presentation will also be available in the Investors' Events & Presentations section of the Company's website, www.ateapharma.com. An archived webcast will be available on the Atea website approximately two hours after the event.

    About the AT-527 COVID-19 Clinical Development Program

    AT-527 is an orally administered, direct-acting antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in the global Phase 3 MORNINGSKY trial, a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 outpatient study in patients with mild or moderate COVID-19.

    Direct-acting antivirals, such as AT-527, aim to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing, or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes AT-527 well suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the safety, efficacy and demand for our product candidates, in particular AT-527; plans and timing for clinical trials and data; our strategic collaboration with Roche; and our competitive position. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19 and our other product candidates; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our most recent Quarterly Report on Form 10-Q, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



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  9. BOSTON, May 06, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it will host a live conference call and audio webcast on Thursday, May 13, 2021 at 4:30 p.m. ET to report financial results for the first quarter ended March 31, 2021, and to provide a corporate update.

    To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time, and refer to conference ID 8609279. A live audio webcast of the call and accompanying slide presentation will be available in the Investors' Events & Presentations section of the Company's website, www.ateapharma.com. An archived webcast…

    BOSTON, May 06, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it will host a live conference call and audio webcast on Thursday, May 13, 2021 at 4:30 p.m. ET to report financial results for the first quarter ended March 31, 2021, and to provide a corporate update.

    To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time, and refer to conference ID 8609279. A live audio webcast of the call and accompanying slide presentation will be available in the Investors' Events & Presentations section of the Company's website, www.ateapharma.com. An archived webcast will be available on the Atea website approximately two hours after the event.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com



    View Full Article Hide Full Article
  10. BOSTON, April 29, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in the Phase 3 MORNINGSKY trial, a global multicenter trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial, which is anticipated to enroll approximately 1,400 non-hospitalized adults and adolescents with mild to moderate COVID-19, is currently enrolling patients at clinical trial sites outside the United States. MORNINGSKY is expected to have an extensive global footprint and will include a large number of clinical sites worldwide, including Japan.

    AT-527 is an orally administered, direct-acting antiviral…

    BOSTON, April 29, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in the Phase 3 MORNINGSKY trial, a global multicenter trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial, which is anticipated to enroll approximately 1,400 non-hospitalized adults and adolescents with mild to moderate COVID-19, is currently enrolling patients at clinical trial sites outside the United States. MORNINGSKY is expected to have an extensive global footprint and will include a large number of clinical sites worldwide, including Japan.

    AT-527 is an orally administered, direct-acting antiviral in development and derived from Atea's purine nucleotide prodrug platform. Under a strategic collaboration, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19.

    "This pivotal milestone demonstrates a focused effort with our strategic partner Roche to globally advance the development of an oral therapeutic for COVID-19 that has the potential for broad use in early stages of the disease," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "With the initiation of this global Phase 3 program, we are one step closer to achieving our goal of providing an easily administered oral, direct-acting antiviral in the fight against this global pandemic."

    Dr. Sommadossi continued, "As a direct-acting antiviral, AT-527 aims to prevent disease progression by inhibiting viral replication and thereby reducing the severity of disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it well-suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines."

    AT-527 targets SARS-CoV-2 ribonucleic acid (RNA) polymerase (nsp12), a highly conserved gene which is responsible for both viral RNA replication and transcription. Given this preferential conserved target site, it is anticipated that the antiviral activity of AT-527 will continue even in the presence of naturally-evolving variants, which are now spreading globally.

    About the Phase 3 MORNINGSKY Trial

    MORNINGSKY is a Phase 3 multicenter, randomized, double-blind, placebo-controlled, outpatient study to evaluate the efficacy, safety, pharmacokinetic profile and antiviral activity of AT-527 in patients with mild or moderate COVID-19. The study is expected to enroll approximately 1,400 non-hospitalized patients, including adolescents with confirmed mild to moderate acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection. Patients will be randomized within 5 days of symptom onset. At the time of enrollment, patients must be stable and not require hospitalization. The primary endpoint, evaluating the efficacy of AT-527 compared with placebo, will measure the time to alleviation or improvement of COVID-19 symptoms. Other efficacy endpoints will include number of patients requiring medically attended visits or hospitalization for COVID-19. Additionally, among other secondary and exploratory endpoints, the study will also identify and/or evaluate biomarkers that are predictive of an antiviral response to AT-527.

    About the AT-527 COVID-19 Clinical Development Program

    AT-527 is an orally administered, direct-acting antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, in addition to the Phase 3 MORNINGSKY trial, AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study in patients with mild or moderate COVID-19 in an outpatient setting.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the safety, efficacy and demand for our product candidates, in particular AT-527; plans and timing for clinical trials and data; our strategic collaboration with Roche; our leadership; the sufficiency of our cash and cash equivalents to fund our operations; our competitive position and our participation in upcoming presentations and conferences. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

     



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  11. – Rapid advancement of AT-527 for COVID-19 –

    – Strategic collaboration with Roche to develop and commercialize AT-527 for COVID-19 –

    – Initiation of Phase 1a trial of AT-752 for dengue fever –

    – Crossover financing and IPO –

    BOSTON, March 30, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today reported financial results for the year ended December 31, 2020 and provided a corporate update.

    "For Atea, 2020 was a transformational year that placed our direct acting antiviral platform at the forefront of the fight against COVID-19. Not only did we act quickly to advance our lead product candidate AT-527 in response to the global pandemic, but we also signed a strategic…

    – Rapid advancement of AT-527 for COVID-19 –

    – Strategic collaboration with Roche to develop and commercialize AT-527 for COVID-19 –

    – Initiation of Phase 1a trial of AT-752 for dengue fever –

    – Crossover financing and IPO –

    BOSTON, March 30, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today reported financial results for the year ended December 31, 2020 and provided a corporate update.

    "For Atea, 2020 was a transformational year that placed our direct acting antiviral platform at the forefront of the fight against COVID-19. Not only did we act quickly to advance our lead product candidate AT-527 in response to the global pandemic, but we also signed a strategic partnership agreement with Roche, effected a significant crossover financing, and became a publicly traded company," said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. "With Roche, which has unparalleled global capabilities in antiviral development and commercialization, we have been able to accelerate the late-stage development of AT-527. With the upcoming initiation of the global Phase 3 program, we are one step closer to achieving our goal of providing an easily administered and widely generalizable, oral, direct-acting antiviral to assist in the fight against this global pandemic."

    "Looking ahead, during the second quarter of 2021, in addition to starting the Phase 3 clinical trial of AT-527 for the treatment of outpatients with mild or moderate COVID-19, we expect to report interim virology data from two ongoing Phase 2 trials of AT-527. We also have recently made significant progress in further understanding AT-527's unique mechanism of action. Our work has elucidated for the first time the impairment of the NiRAN domain, a critical part of the viral RNA polymerase complex, which is essential for the transcription and replication of SARS-CoV-2. Given this preferential conserved target site, we believe that AT-527 will maintain its antiviral activity even in the presence of naturally-evolving variants which are now emerging," said Dr. Sommadossi. "We entered 2021 in a strong position to advance our strategy, as we've built an experienced and talented leadership team, and we are well-funded to support the important work of bringing oral antiviral products as quickly as possible to patients worldwide who are facing difficult to treat, severe viral diseases."

    AT-527 Recent Clinical Development Highlights

    Phase 2 Trial of AT-527 in Outpatient Setting

    • In February 2021, Atea announced the first patient dosed in a Phase 2 clinical trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial, which is being conducted in collaboration with Roche, will enroll up to 220 patients in the United Kingdom, Ireland, and other countries. The randomized, double-blind, multi-center, placebo-controlled Phase 2 trial will evaluate the antiviral activity, safety, and pharmacokinetics of AT-527 550 mg administered twice-daily in adult patients with mild or moderate COVID-19 in an outpatient setting. The primary endpoint of this trial is change from baseline in amount of SARS-CoV-2 virus RNA as measured by reverse transcription polymerase chain reaction (RT-PCR) at specified timepoints.

    Phase 2 Trial of AT-527 in Hospitalized Setting

    • The ongoing Phase 2 trial in the hospitalized setting is a randomized, double-blind, placebo-controlled, multi-center, global trial of AT-527, which is expected to enroll approximately 190 hospitalized patients with moderate COVID-19. The primary efficacy endpoint of this trial is the change in level of respiratory insufficiency. Other important outcomes to be assessed are the effect of AT-527 versus placebo on the viral kinetics of the infection and the elucidation of the safety and tolerability of AT-527 at the dose of 550 mg administered twice-daily.

    Presentation of Positive AT-527 Phase 1 Healthy Volunteer Data at CROI

    • In March 2021, the Company presented favorable results from a Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI). The study results showed AT-527 was well tolerated with no discontinuations or serious adverse events and no clinically significant changes in vital signs or electrocardiograms were observed. The data also demonstrated that AT-511 (the free base of AT-527) was rapidly absorbed followed by fast and extensive stepwise metabolic activation to the active triphosphate AT-9010, reflected by plasma AT-273. Steady state levels were quickly achieved by the third dose of AT-527. The Phase 1 study results validate the modeling from our preclinical animal models which predict that lung levels will consistently be above the EC90 level of 0.5 uM.

    AT-527 Overview of AT-527 at ICAR

    • In March 2021, at the invitation of the organizers of the 34th International Conference on Antiviral Research (ICAR), Atea presented an overview of AT-527, including the Phase 1 study data as well as preclinical data and the underlying mechanistic rationale supporting the use of AT-527 for the treatment of COVID-19.

    Publication of Preclinical Data Highlighting Potency of AT-527 Against SARS-CoV-2

    • In February 2021, the Company announced the publication of new data highlighting the highly potent in vitro antiviral activity of AT-527 against SARS-CoV-2. The new findings were made available in a manuscript published online in Antimicrobial Agents and Chemotherapy. These data underscore key mechanistic features enabling AT-527 to inhibit SARS-CoV-2 viral replication and support Atea's current late-stage clinical development program.

    AT-752 Recent Clinical Development Highlights

    Phase 1a Trial for Dengue Fever

    • In December 2020, Atea filed a Clinical Trial Application for AT-752 in Australia. In March 2021, the Company initiated a randomized, double-blind, placebo-controlled, single- and multiple-ascending dose Phase 1a study that will evaluate the safety, tolerability, and pharmacokinetics of AT-752 in healthy subjects. The Phase 1a study is expected to enroll up to 60 subjects. The objective of the study is to establish the safety and tolerability of AT-752 and also to support dose selection for future studies of AT-752 as a treatment for dengue fever.

    Recent Corporate Highlights

    Added to the Russell 2000® Index 

    • Effective December 21, 2020, Atea was added to the Russell 2000® Index as part of the index's quarterly initial public offering (IPO) additions.

    Closing of Initial Public Offering

    • In November 2020, Atea announced the closing of its IPO of 14,375,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,875,000 additional shares of common stock, at a public offering price of $24.00 per share. The aggregate net proceeds to Atea from the offering were $317.6 million after deducting underwriting discounts and commissions and other offering expenses.

    Strategic Collaboration with Roche to Develop and Commercialize AT-527 for COVID-19

    • In October 2020, Atea entered into an agreement with Roche ((SIX: RO, ROG, OTCQX:RHHBY) pursuant to which Atea licensed to Roche the exclusive rights to research, develop, and distribute AT-527 as an antiviral treatment for COVID-19 in territories outside of the United States. Under the terms of the agreement, Atea received an upfront payment of $350 million in cash from Roche with the potential for future milestone payments and royalties.



    • In February 2021, Atea announced that Chugai Pharmaceutical Co., Ltd. (TYO:4519) in-licensed from Roche the rights to develop and market AT-527 for the treatment of COVID-19 in Japan.

    Senior Management Appointments

    In January 2021, Atea announced the expansion of its senior management team with the appointments of Jayanthi Wolf, Ph.D., Senior Vice President of Regulatory Affairs and Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications. Dr. Wolf has had an extensive career in research and development at Merck over a 19-year period. Ms. Barnes has more than 20 years of experience in the pharmaceutical and biotechnology industry.

    Full Year 2020 Financial Results

    Cash and Cash Equivalents: $850.1 million at December 31, 2020 compared to $21.7 million at December 31, 2019.

    Revenue: Collaboration revenue for the year ended December 31, 2020 in the amount of $48.6 million was derived from the Roche License Agreement that was executed in October 2020.

    Research and Development Expenses: Research and development expenses for the year ended December 31, 2020 in the amount of $38.0 million increased by $27.8 million from $10.2 million for the year ended December 31, 2019. The increase in research and development expenses was primarily due to an increase in external expenses incurred related to contract research organization and contract manufacturing organization services in connection with the advancement of product candidates for the treatment of COVID-19 and dengue and an increase in personnel-related expenses, including salaries and bonuses, benefits and stock-based compensation expense for our research and development employees and consulting fees.

    General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2020 in the amount of $21.6 million increased by $17.2 million from $4.4 million for the year ended December 31, 2019 primarily due to the expansion of our organization resulting in an increase in payroll and personnel-related expenses, including salaries, benefits, and stock-based compensation expense. Additionally, general and administrative expenses for the year ended December 31, 2020 include consulting fees in the amount $7.0 million paid to a financial advisor in connection with the Roche License Agreement.

    Net loss: Net loss for the year ended December 31, 2020 in the amount of $10.9 million decreased by $3.1 million from $14.0 million for the year ended December 31, 2019.

    Consolidated Statement of Operations

    (in thousands, except share and per share data)
      Year Ended December 31,
       2020   2019 
         
    Collaboration revenue $48,633  $ 
    Operating expenses:    
    Research and development  38,023   10,170 
    General and administrative  21,640   4,438 
    Total operating expenses  59,663   14,608 
    Loss from operations  (11,030)  (14,608)
    Interest income and other, net  83   574 
    Net and comprehensive loss 

    $


    (10,947


    )
     $(14,034)
    Net loss per share attributable to common stockholders, basic and diluted $(0.51) $(1.39)
    Weighted-average shares outstanding, basic and diluted  21,592,441   10,091,100 



    Selected Consolidated Balance Sheet Data

    (in thousands)
      December 31,
       2020  2019 
         
    Cash and cash equivalents $850,117 $21,661 
    Working capital(1) $547,682 $19,475 
    Total assets $863,632 $22,073 
    Deferred revenue $301,367 $- 
    Convertible preferred stock $- $69,114 
    Total stockholders' equity (deficit) $547,801 $(49,571)
         
    (1) The Company defines working capital as current assets less current liabilities. See the Company's consolidated financial statements in its Annual Report on Form 10K for the year ended December 31, 2020 for further detail regarding its current assets and current liabilities.

    Conference Call and Webcast

    Atea will host a conference call and live audio webcast to discuss full-year 2020 financial results and provide a corporate update today at 4:30 p.m. ET. To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time and refer to conference ID 3282077.

    A live audio webcast of the call with accompanying slide presentation will also be available in the Investors' Events & Presentations section of the Company's website, https://ir.ateapharma.com/news-and-events/events-and-presentations. An archived webcast will be available on the Atea website approximately two hours after the event.

    About AT-527

    AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study in patients with mild or moderate COVID-19 in an outpatient setting. A pivotal Phase 3 trial is planned in the outpatient setting.

    A direct-acting antiviral aims to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it well suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the safety, efficacy and demand for our product candidates, in particular AT-527; plans and timing for clinical trials and data; our strategic collaboration with Roche; our leadership; the sufficiency of our cash and cash equivalents to fund our operations; our competitive position and our participation in upcoming presentations and conferences. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: uncertainty around and costs associated with the development of AT-527 as a potential treatment for COVID-19; dependence on management, directors and other key personnel; the impact of the COVID-19 pandemic on our business; our limited operating history and significant losses since inception; our need for substantial additional funding; our ability to use our net operating loss carryforwards; our dependence on the success of our most advanced product candidates; risks related to the regulatory approval process; risks associated with the clinical development process; risks related to healthcare laws and other legal compliance matters; risks related to potential commercialization; risks related to manufacturing and our dependence on third parties; risks relating to intellectual property; our ability to maintain effective internal control over financial reporting and the significant costs as a result of operating as a public company. These and other important factors discussed under the caption "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2020 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



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  12. BOSTON, March 23, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it will host a live conference call and audio webcast on Tuesday, March 30, 2021 at 4:30 p.m. ET to report financial results for the fourth quarter and full-year ended December 31, 2020, and to provide a business overview.

    To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time, and refer to conference ID 3282077. A live audio webcast of the call with accompanying slide presentation will also be available in the Investors' Events & Presentations section of the Company's website, https://ir.ateapharma.com/news-and-events/events-and-presentations

    BOSTON, March 23, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it will host a live conference call and audio webcast on Tuesday, March 30, 2021 at 4:30 p.m. ET to report financial results for the fourth quarter and full-year ended December 31, 2020, and to provide a business overview.

    To access the live conference call, please dial (833) 301-1150 (domestic) or (914) 987-7391 (international) at least five minutes prior to the start time, and refer to conference ID 3282077. A live audio webcast of the call with accompanying slide presentation will also be available in the Investors' Events & Presentations section of the Company's website, https://ir.ateapharma.com/news-and-events/events-and-presentations. An archived webcast will be available on the Atea website approximately two hours after the event.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing, and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations 

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



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  13. High Lung Levels of Active Triphosphate Predicted with Oral AT-527 for COVID-19 Patients

    Data Supportive of AT-527 550 mg BID Dosing Regimen

    BOSTON, March 06, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI) in a Science Spotlight presentation. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform and is in Phase 2 clinical development for the treatment of COVID-19. AT-527 targets SARS-CoV-2 ribonucleic acid (RNA) polymerase (nsp12…

    High Lung Levels of Active Triphosphate Predicted with Oral AT-527 for COVID-19 Patients

    Data Supportive of AT-527 550 mg BID Dosing Regimen

    BOSTON, March 06, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI) in a Science Spotlight presentation. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform and is in Phase 2 clinical development for the treatment of COVID-19. AT-527 targets SARS-CoV-2 ribonucleic acid (RNA) polymerase (nsp12), a highly conserved gene which is responsible for both viral RNA replication and transcription. Given this preferential conserved target site, it is anticipated that the antiviral activity of AT-527 will continue even in the presence of naturally-evolving variants which are now emerging.

    "We were delighted to present these encouraging results at CROI. Since the respiratory tract is the initiation site of the SARS-CoV-2 infection, these data demonstrate the potential for AT-527, our oral antiviral, to have meaningful clinical uptake in the lungs. Specifically, the data demonstrating rapid attainment of steady state with a fast build-up of trough levels enables us to predict that there should be exposure of drug in the lung above levels that are needed to inhibit viral replication," said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. "In addition, these results show that AT-527 was well tolerated with a favorable safety and pharmacokinetic profile and are supportive of the dosing regimen for the upcoming Phase 3 program."

    In the Phase 1 study, 20 healthy volunteers were randomized 1:1 to receive oral AT-527 550 mg twice daily (BID) or matching placebo for 5 days. The purpose of this study was to assess the safety and pharmacokinetics (PK) of AT-527 in healthy volunteers and to predict human lung exposure of intracellular AT-9010, the active triphosphate (TP) metabolite of AT-527. Safety assessments included adverse events (AEs), vital signs, electrocardiograms (ECGs), and standard safety laboratory tests. Intensive PK sampling, performed after the first and last two doses, provided information on plasma exposures of AT-511, the free base of AT-527, a hemisulfate salt, and its metabolites including AT-273, the guanosine nucleoside metabolite, a measurable surrogate for intracellular AT-9010.

    The study results showed AT-527 was well tolerated with a favorable safety profile. There were no discontinuations, serious AEs, clinically significant changes in vital signs, or ECGs observed. The data also demonstrated that AT-511 was rapidly absorbed, followed by fast and extensive stepwise metabolic activation ultimately to the intracellular TP metabolite AT-9010, reflected by plasma AT-273. AT-527 550 mg BID led to fast attainment of steady-state levels of AT-273 within two days of dosing. Plasma levels of AT-273 were further used to predict lung concentrations of AT-9010 using a scaling factor of 1.2X which was previously determined from in vivo tissue distribution of the triphosphate metabolite in cynomolgus monkeys. Beginning as early as three hours after the first dose, and maintained thereafter throughout the five days of dosing, predicted lung AT-9010 levels were consistently above the EC90 level of 0.5 µM for in vitro inhibition by the drug of SARS-CoV-2 replication. These results indicate the potential of AT-527 for the treatment of COVID-19 and are supportive of the dosing regimen of 550 mg BID.

    About AT-527

    AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study in patients with mild or moderate COVID-19 in an outpatient setting. A pivotal Phase 3 trial is planned in the outpatient setting.

    A direct-acting antiviral aims to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it well suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing, and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



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  14. BOSTON, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that Chugai Pharmaceutical Co., Ltd. (TYO:4519) has in-licensed the rights for AT-527 for the treatment of COVID-19 in Japan from Roche ((SIX: RO, ROG, OTCQX:RHHBY). Under a strategic collaboration, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19 and Roche has the right to commercialize AT-527 outside of the United States. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform and is in Phase 2 development for the treatment of COVID-19.

    "This agreement between Roche and Chugai underscores…

    BOSTON, Feb. 19, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that Chugai Pharmaceutical Co., Ltd. (TYO:4519) has in-licensed the rights for AT-527 for the treatment of COVID-19 in Japan from Roche ((SIX: RO, ROG, OTCQX:RHHBY). Under a strategic collaboration, Roche and Atea are jointly developing AT-527 for the treatment of COVID-19 and Roche has the right to commercialize AT-527 outside of the United States. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform and is in Phase 2 development for the treatment of COVID-19.

    "This agreement between Roche and Chugai underscores a commitment to global accessibility of AT-527 to fight COVID-19 and accelerates its entry into this important Asian market," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "We are delighted that Chugai, who is closely aligned with Roche through a strategic alliance, will undertake this important work, as they have commercial and development expertise and are a market leader in Japan."

    Atea and Roche announced a strategic collaboration on October 22, 2020. The collaboration aims to accelerate the clinical development and manufacturing of AT-527, to investigate its safety and efficacy, and to provide this potential treatment option to patients around the world as quickly as possible.

    About AT-527

    AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study in patients with mild or moderate COVID-19 in an outpatient setting. A pivotal Phase 3 trial is planned in the outpatient setting.

    A direct-acting antiviral aims to prevent disease progression by minimizing or eliminating viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it well suited for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



    View Full Article Hide Full Article
  15. BOSTON, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced the publication of new data highlighting the highly potent in vitro antiviral activity of AT-527 against SARS-CoV-2. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform. The new findings are available in a manuscript published online in Antimicrobial Agents and Chemotherapy.

    "To be effective, a direct-acting antiviral needs to be administered orally, and early, in the course of viral infection in order to inhibit viral replication and thereby reduce disease progression. These new data underscore AT-527's potential…

    BOSTON, Feb. 08, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced the publication of new data highlighting the highly potent in vitro antiviral activity of AT-527 against SARS-CoV-2. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea's purine nucleotide prodrug platform. The new findings are available in a manuscript published online in Antimicrobial Agents and Chemotherapy.

    "To be effective, a direct-acting antiviral needs to be administered orally, and early, in the course of viral infection in order to inhibit viral replication and thereby reduce disease progression. These new data underscore AT-527's potential to treat COVID-19 and to have an impact on global health," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "The results demonstrated in several in vitro assays that AT-527 has highly potent antiviral activity against several human coronaviruses, including SARS-CoV-2, the causative agent of COVID-19. AT-527 was activated in cultured normal human nasal and bronchial epithelial cells, which are the primary targets of SARS-CoV-2 infection. Since the respiratory tract is the initial site of the SARS-CoV-2 infection, activation of AT-527 with its substantial half-life suggests sustained inhibition of viral replication of SARS-CoV-2 in these tissues."

    Antiviral therapeutics are expected to have the greatest effect if given in early stages of the COVID-19 infection when SARS-CoV-2 is rapidly replicating in the respiratory epithelium and viral load levels are high. The goal of a direct-acting antiviral is to prevent disease progression by minimizing, or eliminating, viral replication and thereby reducing the severity of the disease, preventing or shortening hospitalization, and also potentially preventing transmission of the virus to others. This makes it ideal for potential use in both pre- and post-exposure prophylactic settings and complementary to vaccines.

    In several in vitro assays, AT-511, which is the freebase of AT-527, demonstrated highly potent activity in inhibiting the replication of SARS-CoV-2, the virus responsible for the COVID-19 pandemic. The results show that AT-511 is extensively activated in the key human primary cells, nasal and bronchial epithelial cells. Importantly, the half-life observed in these primary human cells of the upper and lower respiratory tract was approximately 40 hours, which is a key pharmacokinetic /pharmacodynamic (PK/PD) characteristic that allows accumulation of the active triphosphate metabolite of the drug candidate in these key tissues, thus resulting in the potent inhibition of SARS-CoV-2 viral replication by AT-527.

    A simulation using human PK data combined with non-human primate tissue levels was also detailed in the manuscript. The data indicate that within two hours of dosing, AT-9010 (triphosphate active metabolite of AT-527) achieved concentrations that should inhibit SARS-CoV-2 replication and that these effective levels should be maintained throughout therapy. Based on these data, a twice-daily oral regimen of AT-527 at 550 mg is currently being studied in clinical trials.

    In addition, the authors discussed RNA polymerase (nsp12) of SARS-CoV-2 and other coronaviruses, focusing on two functional domains, including RdRp and nidovirus RdRp-associated nucleotidyltransferase (NiRAN). Recent data indicate that AT-9010 (triphosphate active metabolite of AT-527) is a potent inhibitor of NiRAN, a function essential for viral replication. These findings will be published in an upcoming manuscript.

    Data Highlights

    In cultured normal human airway epithelial cells, the concentration of AT-511 required to inhibit replication of SARS-CoV-2 by 90% (EC90) was 0.47 µM, very similar to its EC90 against HCoV-229E, HCoV-OC43 and SARS-CoV in Huh-7 cells. Little to no cytotoxicity was observed for AT-511 at concentrations up to 100 µM. Substantial levels of the active triphosphate metabolite AT-9010 were formed in normal human bronchial and nasal epithelial cells incubated with 10 µM AT-511 (698 ± 15 and 236 ± 14 µM, respectively), with a half-life of at least 38 hours. Results from steady-state pharmacokinetic and tissue distribution studies of non-human primates administered oral doses of AT-527, as well as pharmacokinetic data from subjects given daily oral doses of AT-527, predict that twice daily oral doses of 550 mg AT-527 will produce AT-9010 trough concentrations in human lung that exceed the EC90 observed for the prodrug against SARS-CoV-2 replication. This suggests that AT-527 may be an effective treatment option for COVID-19.

    About AT-527

    AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. In collaboration with Roche, AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study in an outpatient setting. A pivotal Phase 3 trial is planned in the outpatient setting.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



    View Full Article Hide Full Article
  16. BOSTON, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in the Phase 2 virology trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial will enroll patients in the United Kingdom (UK), Ireland and other countries. AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea's purine nucleotide prodrug platform.

    "In collaboration with Roche, we are initiating a randomized virology study in the UK and Ireland, where COVID-19 is fast-spreading and an estimated 30-40% of new infections involve a new mutation. This study presents the…

    BOSTON, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in the Phase 2 virology trial evaluating AT-527 in mild or moderate COVID-19 patients in an outpatient setting. The trial will enroll patients in the United Kingdom (UK), Ireland and other countries. AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea's purine nucleotide prodrug platform.

    "In collaboration with Roche, we are initiating a randomized virology study in the UK and Ireland, where COVID-19 is fast-spreading and an estimated 30-40% of new infections involve a new mutation. This study presents the opportunity to investigate the antiviral activity of AT-527 in these patients. Importantly, this study is evaluating patients in an outpatient setting, which is the anticipated patient population of the upcoming Phase 3 trial," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "While vaccines will play an important role in controlling the COVID-19 pandemic, we need additional treatment options to stay ahead of the virus, and direct-acting antivirals have the potential to be an essential complement to vaccines."

    AT-527 has been shown to inhibit viral replication of SARS-CoV-2 in vitro. The ultimate goal is to effectively address the ongoing need for a safe and effective oral antiviral that is suitable for easy and early administration to reduce the severity of the disease, thereby reducing the burden on the global healthcare system.

    The randomized, double-blind, placebo-controlled Phase 2 trial will evaluate the antiviral activity, safety, and pharmacokinetics of AT-527 550 mg twice-daily in adult patients with mild or moderate COVID-19 in an outpatient setting. There will be multiple cohorts included in the trial investigating potentially alternative dosing regimens in addition to the 550 mg twice-daily dosing. The study will enroll up to 220 patients in the UK, Ireland and other countries.

    The primary endpoint of this trial is change from baseline in amount of SARS-CoV-2 virus RNA as measured by reverse transcription polymerase chain reaction (RT-PCR) at specified timepoints.

    "We look forward to rapid enrollment of this important study and hope it will provide further evidence of AT-527's antiviral activity against SARS-CoV-2. Our goal is to provide as soon as possible an easily administered and widely accessible treatment to fight this global pandemic and to treat and curtail its spread worldwide," said Janet Hammond, MD, Ph.D., Chief Development Officer of Atea Pharmaceuticals.

    About AT-527

    AT-527 is an orally administered, direct-acting developmental antiviral agent derived from Atea's nucleotide prodrug platform. AT-527 is currently under evaluation as a treatment for patients with COVID-19. AT-527 is currently being evaluated in a global Phase 2 study for hospitalized patients with moderate COVID-19 and a Phase 2 virology study. A pivotal Phase 3 trial is planned in the outpatient setting.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing, and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



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  17. Senior executives bring proven industry experience to leadership roles in regulatory affairs and communications

    BOSTON, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it has expanded its senior management team with the appointments of Jayanthi Wolf, Ph.D., Senior Vice President of Regulatory Affairs and Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications.

    "We are very pleased to welcome Jayanthi and Jonae to Atea," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "They bring with them extensive and highly valuable industry experience, which will expand Atea's…

    Senior executives bring proven industry experience to leadership roles in regulatory affairs and communications

    BOSTON, Jan. 19, 2021 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it has expanded its senior management team with the appointments of Jayanthi Wolf, Ph.D., Senior Vice President of Regulatory Affairs and Jonae Barnes, Senior Vice President of Investor Relations and Corporate Communications.

    "We are very pleased to welcome Jayanthi and Jonae to Atea," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "They bring with them extensive and highly valuable industry experience, which will expand Atea's capability as we continue to advance our corporate initiatives and our product candidates, including moving forward with the Phase 3 program for AT-527 for COVID-19 and AT-752 as a potential therapeutic for Dengue fever."

    Dr. Wolf has had an extensive career in research and development at Merck over a 19-year period. During her tenure at Merck, she served in a series of roles ranging from scientific to safety assessment and regulatory, with increasing responsibility in global regulatory affairs and clinical safety. Dr. Wolf has broad experience in regulatory affairs, including clinical, nonclinical and manufacturing and has managed programs from preclinical development through regulatory approval. She served as the global regulatory team leader for several products, including ERVEBO®, the first Ebola vaccine approved by the U.S. Food and Drug Administration, the European Medicines Agency and prequalified by the World Health Organization. Dr. Wolf earned a Ph.D. and master's degree in molecular biology and immunology from Princeton University and a B.S. in biochemistry from Susquehanna University.

    Ms. Barnes has more than 20 years of experience in the pharmaceutical and biotechnology industry. Her experience in strategic investor relations and corporate communications spans the full life cycle of drug development and commercialization. She began her career at Sepracor (now Sunovion Pharmaceuticals; acquired by Dainippon Sumitomo Pharma Co.), where she held a series of progressively responsible management and executive roles over a 14-year period and served most recently as Senior Vice President, Investor Relations, Corporate Communications and Internal Communications. Ms. Barnes has also served in senior leadership roles at several biotechnology companies including Idenix Pharmaceuticals, Agenus, and most recently at Poxel SA. Ms. Barnes earned a B.S. in political science from Suffolk University and master's degrees in financial economics and multinational commerce from Boston University.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Jonae Barnes

    SVP, Investor Relations and Corporate Communications

    617-818-2985

    Barnes.jonae@ateapharma.com 

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com 

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com 



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  18. BOSTON, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced that Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 9:10 a.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea…

    BOSTON, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced that Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea will present a corporate overview at the 39th Annual J.P. Morgan Healthcare Conference on Monday, January 11, 2021 at 9:10 a.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary purine nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



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  19. BOSTON, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it has been added to the Russell 2000® Index, effective December 21, 2020, as part of the index's quarterly initial public offering (IPO) additions.

    "We are pleased to be added to the Russell 2000 Index, which will help to broaden our investor base and increase awareness of our Company's mission of discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "In particular, we look forward to expanding visibility…

    BOSTON, Dec. 18, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that it has been added to the Russell 2000® Index, effective December 21, 2020, as part of the index's quarterly initial public offering (IPO) additions.

    "We are pleased to be added to the Russell 2000 Index, which will help to broaden our investor base and increase awareness of our Company's mission of discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases," said Jean-Pierre Sommadossi, Ph.D., Founder and Chief Executive Officer of Atea Pharmaceuticals. "In particular, we look forward to expanding visibility of our novel antiviral product candidates, including AT-527 for the treatment of COVID-19, and our proprietary purine nucleotide prodrug platform to the investment community."

    Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

    For more information on the Russell 2000 Index and the Russell indexes IPO additions, please visit the "Russell U.S. Index IPO Additions" section on the FTSE Russell website.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary purine nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



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  20. BOSTON, Nov. 25, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced that management will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Thursday, December 3, 2020 at 12:35 p.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused…

    BOSTON, Nov. 25, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced that management will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on Thursday, December 3, 2020 at 12:35 p.m. ET.

    A live webcast of the presentation will be available on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary nucleotide and nucleoside prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally- available, potent, and selective purine nucleotide and nucleoside prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, hepatitis C virus (HCV) infection, dengue virus, and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com



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  21. BOSTON, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced the appointment of Barbara Duncan to its Board of Directors, where she will also serve as Chair of the Audit Committee.

    "We are delighted to welcome Barbara to the Atea Board of Directors. Her financial acumen combined with her considerable experience advising a variety of biopharmaceutical companies will make Barbara's guidance invaluable to Atea as we navigate the public markets and advance our antiviral pipeline," said Jean-Pierre…

    BOSTON, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced the appointment of Barbara Duncan to its Board of Directors, where she will also serve as Chair of the Audit Committee.

    "We are delighted to welcome Barbara to the Atea Board of Directors. Her financial acumen combined with her considerable experience advising a variety of biopharmaceutical companies will make Barbara's guidance invaluable to Atea as we navigate the public markets and advance our antiviral pipeline," said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals.

    "I am proud to join Atea at this critical juncture as the Company recently transitioned to a publicly traded entity," said Ms. Duncan. "Importantly, I am excited to be a part of the team working to make a difference in this global pandemic through the advancement of AT-527, an oral product candidate for the treatment of patients suffering from COVID-19."

    Ms. Duncan previously served as Chief Financial Officer and Treasurer at Intercept Pharmaceuticals. Prior to her leadership role with Intercept, Ms. Duncan was Chief Financial Officer and then Chief Executive Officer at DOV Pharmaceutical, which was sold to Euthymics Bioscience. Before that, she served as Vice President of Corporate Finance - Global Healthcare at Lehman Brothers and as Director of Corporate Finance at SBC Warburg Dillon Read. Ms. Duncan currently serves on the Board of Directors of Adaptimmune Therapeutics, Fusion Pharmaceuticals, Jounce Therapeutics, ObsEva SA, and OVID Therapeutics.

    Ms. Duncan received an M.B.A. from the Wharton School, University of Pennsylvania and a B.S. from Louisiana State University.

    About Atea Pharmaceuticals

    Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleoside biology, and medicinal chemistry, Atea has built a proprietary purine nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, hepatitis C virus (HCV) infection, dengue virus, and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.

    Contacts

    Investors:

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com

    View Full Article Hide Full Article
  22. BOSTON, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced the closing of its initial public offering of 14,375,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,875,000 additional shares of common stock, at a public offering price of $24.00 per share. The aggregate gross proceeds to Atea from the offering were $345 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares…

    BOSTON, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announced the closing of its initial public offering of 14,375,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 1,875,000 additional shares of common stock, at a public offering price of $24.00 per share. The aggregate gross proceeds to Atea from the offering were $345 million, before deducting underwriting discounts and commissions and other offering expenses. All of the shares in the offering were offered by Atea Pharmaceuticals. Atea's common stock began trading on the Nasdaq Global Select Market under the ticker symbol "AVIR" on October 30, 2020.

    J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and William Blair & Company, L.L.C. acted as joint book-running managers of the offering.

    A registration statement on Form S-1 (File No. 333-249404) relating to the offering has been filed with the Securities and Exchange Commission and became effective on October 29, 2020. The offering was made only by means of a prospectus. Copies of the final prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 866-803-9204; Morgan Stanley & Co. LLC, 180 Varick Street, 2nd Floor, New York, NY 10014, Attention: Prospectus Department, or by email at prospectus@morganstanley.com; Evercore Group, L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by telephone at (800) 621-0687 or by email at prospectus@williamblair.com.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    Contacts

    Investors:

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    will.oconnor@sternir.com

    Media:

    Carol Guaccero

    301-606-4722

    contactus@ateapharma.com

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