AVIR Atea Pharmaceuticals Inc.

23.5
+0.59  (+3%)
Previous Close 22.91
Open 22.81
52 Week Low 18.72
52 Week High 94.1737
Market Cap $1,944,318,020
Shares 82,736,937
Float 61,022,278
Enterprise Value $1,045,386,226
Volume 769,133
Av. Daily Volume 726,539
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Drug Pipeline

Drug Stage Notes
AT-527 (Outpatient Setting)
COVID-19
Phase 2
Phase 2
Phase 2 trial is enrolling.
AT-527 (MORNINGSKY)
COVID-19
Phase 3
Phase 3
Phase 3 trial initiation announced April 29, 2021.
AT-527
COVID-19 (Non-Hospitalized) - Virology Trial
Phase 2
Phase 2
Phase 2 initiation of dosing announced February 4, 2021.
AT-752
Dengue
Phase 1
Phase 1
Phase 1 trial to be initiated 1H 2021.

Latest News

    • 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

    Will O'Connor

    Stern Investor Relations

    212-362-1200



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  1. 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

    Will O'Connor

    Stern Investor Relations

    212-362-1200



    View Full Article Hide Full Article
  2. 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

    Will O'Connor

    Stern Investor Relations

    212-362-1200

     



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  3. – 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

    Will O'Connor

    Stern Investor Relations

    212-362-1200

    Media:

    Carol Guaccero

    301-606-4722



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  4. 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

    Will O'Connor

    Stern Investor Relations 

    212-362-1200

    Media:

    Carol Guaccero

    301-606-4722



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