Financial Data and Key Metrics Changes - The company reported a cash, cash equivalents, and marketable securities balance of $541.5 million as of March 31, 2024, with a projected runway into 2027 based on strong operational execution and financial discipline [10][22][23] - Research and development expenses increased in Q1 2024 compared to Q1 2023, primarily due to higher external spending related to clinical trials [22] Business Line Data and Key Metrics Changes - The Bemnifosbuvir program for COVID-19 is progressing with a completed enrollment of 2,221 patients in the SUNRISE-3 Phase 3 trial, focusing on high-risk patients [6][18] - The Phase 2 program for hepatitis C (HCV) reported a 98% sustained virologic response (SVR4) rate from the leading cohort of 60 patients, with plans to present new efficacy data at the upcoming EASL conference [8][12][15] Market Data and Key Metrics Changes - The U.S. HCV market demand grew approximately 5% in 2023, with over 2 million individuals estimated to be infected, indicating a significant patient pool for treatment [12] - The market opportunity for oral antiviral therapeutics for COVID-19 is projected to remain a multibillion-dollar opportunity, with annual revenues estimated between $4 billion and $5 billion for the two approved oral antiviral products [21] Company Strategy and Development Direction - The company aims to address unmet medical needs in COVID-19 and HCV treatment through innovative therapies, with a focus on the combination of Bemnifosbuvir and ruzasvir for HCV [11][17] - The company plans to initiate a Phase 3 study for HCV around the end of 2024, following the completion of the current Phase 2 study [9][26] Management's Comments on Operating Environment and Future Outlook - Management highlighted the ongoing evolution of COVID-19 variants and the need for effective treatments, emphasizing the potential of Bemnifosbuvir to meet this demand [6][16] - The company expressed optimism about upcoming data presentations and the potential for significant shareholder value driven by key milestones in both COVID-19 and HCV programs [24][26] Other Important Information - The company is preparing for a Phase 3 study for HCV, with a focus on a fixed-dose combination tablet that aims to minimize pill burden [9][48] - Management indicated that the current cash runway includes plans for potential partnerships in the COVID-19 program while also engaging in initial commercialization activities [58] Q&A Session Summary Question: What percentage of the 220 patients in the HCV trial will be rolling patients? - The target is to enroll at least 10% to 20% of the 220 patients [30] Question: What is the pathway for registration for the HCV trial? - The company anticipates needing two Phase 3 trials, likely one against a comparator, and plans to execute the Phase 3 program independently [32][41] Question: Thoughts on Shionogi's recent Phase 3 update? - Management noted the importance of focusing on hospitalization as a primary endpoint, contrasting it with Shionogi's approach [36] Question: Will the EASL data include long-term SVR results? - New Phase 2 efficacy data will be presented, but specifics on SVR12 cannot be disclosed due to embargo [40] Question: How large of a safety database is needed for registration? - A safety database of around 1,000 patients is typically required for a combination antiviral like this [55]

First Quarter Results and Business Update May 14, 2024 NASDAQ: AVIR June 2020 DISCLAIMERS Forward-Looking Statements This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results and ...

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2024 financials report a net loss of $63.2 million, with $541.5 million in cash and equivalents [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | Account | March 31, 2024 ($ thousands) | December 31, 2023 ($ thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 160,910 | 143,823 | | Marketable securities | 380,581 | 434,283 | | Total current assets | 548,764 | 590,455 | | **Total assets** | **553,029** | **594,968** | | **Liabilities & Equity** | | | | Total current liabilities | 41,311 | 32,376 | | **Total liabilities** | **48,658** | **39,776** | | **Total stockholders' equity** | **504,371** | **555,192** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) | Metric | Three Months Ended March 31, 2024 ($ thousands) | Three Months Ended March 31, 2023 ($ thousands) | | :--- | :--- | :--- | | Research and development | 57,575 | 28,954 | | General and administrative | 12,231 | 12,615 | | **Total operating expenses** | **69,806** | **41,569** | | Loss from operations | (69,806) | (41,569) | | Interest income and other, net | 6,868 | 6,299 | | **Net loss** | **(63,169)** | **(35,467)** | | Net loss per share - basic and diluted | $(0.75) | $(0.43) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | Cash Flow Activity | Three Months Ended March 31, 2024 ($ thousands) | Three Months Ended March 31, 2023 ($ thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (39,865) | (29,850) | | Net cash provided by investing activities | 56,802 | 24,480 | | Net cash provided by financing activities | 150 | 165 | | **Net increase (decrease) in cash** | **17,087** | **(5,205)** | | Cash at end of period | 160,910 | 183,453 | [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biopharmaceutical firm focused on antiviral therapeutics, currently conducting a Phase 3 trial (SUNRISE-3) for bemnifosbuvir for COVID-19 and a Phase 2 trial for a bemnifosbuvir/ruzasvir combination for Hepatitis C (HCV)[26](index=26&type=chunk) - As of March 31, 2024, the company had **$541.5 million** in cash, cash equivalents, and marketable securities, which is believed to be sufficient to fund operations for at least the next twelve months[27](index=27&type=chunk) - Under a license agreement with Merck, Atea is developing ruzasvir in combination with bemnifosbuvir for HCV. The company is obligated to pay future milestone payments, with the first potential milestone of **$5.0 million** payable upon commencing a Phase 3 trial[63](index=63&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses bemnifosbuvir development, noting increased R&D expenses and $541.5 million cash expected to fund operations into 2027 - The company is conducting the SUNRISE-3 Phase 3 trial for bemnifosbuvir in high-risk COVID-19 outpatients, with enrollment completed in March 2024 and results expected in the second half of 2024[72](index=72&type=chunk) - For HCV, a Phase 2 trial of bemnifosbuvir combined with ruzasvir is ongoing. The lead-in cohort showed a **98% SVR4 rate**, meeting the efficacy criteria to continue the study. Final SVR12 results are anticipated in the second half of 2024, with a potential Phase 3 start in the same period[73](index=73&type=chunk) Expense Category | Expense Category | Q1 2024 ($ thousands) | Q1 2023 ($ thousands) | Change ($ thousands) | | :--- | :--- | :--- | :--- | | Research and development | 57,575 | 28,954 | 28,621 | | General and administrative | 12,231 | 12,615 | (384) | | **Total operating expenses** | **69,806** | **41,569** | **28,237** | - The **$28.6 million** increase in R&D expenses was primarily driven by higher external spending on the Phase 3 COVID-19 SUNRISE-3 trial and the Phase 2 HCV combination trial[87](index=87&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Market risk is interest rate sensitivity on $541.5 million cash, with no material impact from a 10% rate change - As of March 31, 2024, the company held **$541.5 million** in cash, cash equivalents, and marketable securities, primarily in interest-bearing money market funds[101](index=101&type=chunk) - The company does not believe that inflation, interest rate changes, or foreign currency fluctuations have had a material impact on its results of operations[101](index=101&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls effective March 31, 2024, with no material changes in internal control - The principal executive officer and principal financial officer concluded that as of March 31, 2024, the company's disclosure controls and procedures were effective[103](index=103&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended March 31, 2024, that have materially affected, or are reasonably likely to materially affect, internal controls[104](index=104&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently subject to any material legal proceedings - The company is not subject to any material legal proceedings[105](index=105&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks including clinical trial uncertainties, competition, regulatory hurdles, manufacturing, intellectual property, and financing - **COVID-19 Development Risks:** There is significant uncertainty around the development of bemnifosbuvir for COVID-19, which faces substantial competition from approved oral antivirals like Pfizer's Paxlovid™ and Merck's Lagevrio™[107](index=107&type=chunk)[109](index=109&type=chunk) - **Financial Risks:** The company has a history of significant operating expenses (**$69.8 million** for Q1 2024) and an accumulated deficit of **$259.0 million**. It will require substantial additional financing to continue its development and commercialization efforts[114](index=114&type=chunk)[116](index=116&type=chunk) - **Clinical and Regulatory Risks:** The business is highly dependent on the success of its most advanced product candidates. The regulatory approval process is lengthy, expensive, and unpredictable, and there is no guarantee of success for its COVID-19 or HCV programs[120](index=120&type=chunk) - **Intellectual Property Risks:** The company faces a patent challenge from Gilead Sciences, which was issued a patent ('361 patent) in May 2023 with a claim that purports to cover bemnifosbuvir. While the company believes the claim is invalid, an adverse legal outcome could require obtaining a license from Gilead, which may not be available on reasonable terms[172](index=172&type=chunk) - **Third-Party Reliance Risks:** The company relies on third parties for manufacturing (CMOs) and conducting clinical trials (CROs). This dependency creates risks related to supply chain disruptions, quality control, and adherence to regulatory standards like cGMP and GCP[162](index=162&type=chunk)[164](index=164&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered equity sales reported; $317.6 million net IPO proceeds invested with no material change - The company completed its IPO on November 3, 2020, raising net proceeds of approximately **$317.6 million**[203](index=203&type=chunk) - There has been no material change in the expected use of the net proceeds from the IPO[204](index=204&type=chunk) [Item 5. Other Information](index=94&type=section&id=Item%205.%20Other%20Information) CEO Jean-Pierre Sommadossi adopted a Rule 10b5-1 trading plan for selling up to 1.2M shares until June 2025 - On March 4, 2024, CEO Jean-Pierre Sommadossi adopted a Rule 10b5-1 trading plan for the sale of up to **1,200,000** shares of common stock, valid until June 4, 2025[205](index=205&type=chunk) [Item 6. Exhibits](index=95&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including CEO/CFO certifications and Inline XBRL

Exhibit 99.1 Atea Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update Full Enrollment Achieved in Global Phase 3 SUNRISE-3 Trial for Treatment of COVID-19 with Results Expected 2H'24 Global Phase 2 HCV Study On Track to Report Complete SVR12 Results 2H'24 Multiple Presentations Showcasing Preclinical and New Phase 2 Ef icacy Data to be Presented at European Association for the Study of the Liver (EASL) Congress 2024 Conference Call at 4:30 pm ET Today BOSTON, Mass., May ...

BOSTON, Mass., May 07, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (NASDAQ:AVIR) ("Atea"), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today announced that it will host a live conference call and audio webcast on Tuesday, May 14, 2024, at 4:30 p.m. ET to report financial results for the first quarter ended March 31, 2024, and to provide a business update. To access the live conference call, participant ...

Core Viewpoint - Atea Pharmaceuticals presented Phase 1 data for bemnifosbuvir, an oral antiviral, at ESCMID 2024, highlighting its favorable safety profile and lack of cardiotoxicity, aiming to address unmet needs in COVID-19 and hepatitis C treatment [1][2][3]. Group 1: Bemnifosbuvir for COVID-19 - Bemnifosbuvir is an oral nucleotide polymerase inhibitor targeting SARS-CoV-2, with a unique mechanism of action that may create a high barrier to resistance [5]. - The global Phase 3 SUNRISE-3 trial has enrolled over 2,200 high-risk patients, focusing on all-cause hospitalization or death as the primary endpoint [4]. - Results from the Phase 1 study indicated no clinically relevant effects on cardiac repolarization or heart rate, confirming preclinical findings of low cardiotoxicity [3][4]. Group 2: Bemnifosbuvir for Hepatitis C Virus (HCV) - Atea is conducting a Phase 2 trial of bemnifosbuvir in combination with ruzasvir for treatment-naïve HCV patients, with a primary endpoint of sustained virologic response at Week 12 post-treatment [6][7]. - In the lead-in cohort of 60 patients, a 98% sustained virologic response rate was observed, indicating strong efficacy [7]. - Bemnifosbuvir has shown to be significantly more active than sofosbuvir against various HCV genotypes, with a favorable pharmacokinetic profile supporting once-daily dosing [8]. Group 3: Company Overview - Atea Pharmaceuticals focuses on developing oral antiviral therapies for serious viral infections, leveraging a proprietary nucleos(t)ide prodrug platform [10]. - The company aims to expand its pipeline by integrating other classes of antivirals alongside its nucleos(t)ide candidates [10].

Financial Data and Key Metrics Changes - The company reported a cash, cash equivalents, and marketable securities balance of $578.1 million as of December 31, 2023, with a runway anticipated to 2026 [11][26]. - Research and development expenses increased for both the fourth quarter and full year 2023 compared to the same periods in 2022, primarily due to external spending related to COVID-19 and HCV clinical trials [26]. Business Line Data and Key Metrics Changes - For the COVID-19 program, the company achieved significant progress in the Phase 3 SUNRISE-3 study, surpassing enrollment of 1,400 patients, which triggered a second interim analysis [9][20]. - In the HCV program, the company confirmed a 98% sustained virological response (SVR4) in the leading cohort of its Phase 2 study, with plans to expand enrollment to 280 patients [10][12]. Market Data and Key Metrics Changes - The U.S. prescription demand for oral antivirals to treat COVID-19 was robust, with approximately 7.7 million prescriptions written in 2023, reflecting a strong market opportunity [24][25]. - The projected annual global market opportunity for COVID-19 oral antivirals is estimated to be over $4 billion to $5 billion, indicating significant unmet needs in the market [25]. Company Strategy and Development Direction - The company aims to develop antiviral drugs for serious viral diseases with significant unmet medical needs, focusing on COVID-19 and HCV treatments [8][10]. - The strategy includes leveraging the Fast Track designation from the FDA for bemnifosbuvir, which is expected to address key limitations of current COVID-19 therapies [6][10]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing need for effective COVID-19 treatments, especially given the emergence of new variants and the limitations of existing therapies [8][19]. - The company anticipates a transformational milestone-rich 2024, with key clinical milestones expected for both the COVID-19 and HCV programs [28]. Other Important Information - The company is conducting Phase 1 studies in the U.S. for the selection of a fixed-dose combination tablet for HCV, with a Phase 3 program anticipated to begin around the end of the year [17][28]. - Management highlighted the importance of developing a best-in-class regimen for HCV that minimizes drug-drug interactions, particularly for patients co-infected with HIV [35][38]. Q&A Session Summary Question: Visibility on patient accrual in SUNRISE-3 - Management indicated that the majority of patients are being assigned to the monotherapy arm due to concerns about drug interactions with combination therapies [33][34]. Question: Significance of non-protease-based inhibitor option for HCV - Management emphasized the importance of being protease-free to reduce drug-drug interactions, particularly for HIV co-infected patients [35][36]. Question: Capital allocation strategy for COVID and HCV programs - Management stated that expenses are expected to increase in a measured way, with preparations for commercialization activities as the Phase 3 programs progress [40][42]. Question: Scenarios for SUNRISE-3 top line data - Management acknowledged the potential impact of preexisting immunity on efficacy and emphasized the importance of the study design to maximize results [44][45]. Question: Ensuring compliance in HCV Phase 3 trial - Management plans to address compliance issues by offering a shorter treatment duration and regular patient follow-ups, with a comparator arm to assess adherence [49][51].

Fourth Quarter and Full Year 2023 Financial and Business Update February 28, 2024 June 2020 NASDAQ: AVIR DISCLAIMERS Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies ...

Exhibit 99.1 Atea Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update Final Results Confirm 98% Sustained Virologic Response Rate at Week 4 Post-Treatment (SVR4) from Lead-in Cohort in Phase 2 HCV Study Enrollment in Phase 3 SUNRISE-3 Study Has Surpassed 1,400 COVID-19 Patients in Monotherapy Population; Two Interim Analyses by Independent Data Safety Monitoring Board (DSMB) Planned for 1H'24 with Topline Results Expected 2H'24 Conference Call at 4:30 pm ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39661 | --- | --- | |---------------------------------------------------------------------------------------------------------|------ ...