RdRp

WATERTOWN, MA, USA I September 26, 2024 I Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating best-in-class small molecule drugs for virology and immunology indications, today announced positive topline results from a Phase 2a human challenge study of EDP-323 in healthy adults infected with respiratory syncytial virus (RSV). These data demonstrated that EDP-323 was generally safe and well-tolerated and achieved an 85-87% reduction in viral load area under the curve (AUC) by qRT-PCR (p<0.0001), a 97-98% reduction in infectious viral load AUC by viral culture (p<0.0001), and a 66-78% reduction of total clinical symptoms score AUC (p<0.0001) compared to placebo. EDP-323, which received Fast Track designation from the U.S. Food and Drug Administration (FDA), is a novel L-protein inhibitor in development as a once-daily oral treatment for RSV. “We are excited about these impressive data that demonstrate a rapid and sustained reduction in viral load. These results are among the strongest ever reported in an RSV challenge study, raising the high bar set by zelicapavir. The significant antiviral activity and symptom alleviation observed in this study highlight EDP-323’s potential as a safe, highly effective, direct-acting antiviral for the treatment of RSV,” said Scott T. Rottinghaus, M.D., Chief Medical Officer of Enanta Pharmaceuticals. “These EDP-323 results represent a meaningful advancement toward achieving our longstanding goal of developing new medicines to treat respiratory infections such as RSV, as there remains a substantial need for safe and effective oral treatments. Enanta has the leading portfolio of potent RSV replication inhibitors, with EDP-323, our L-protein inhibitor, and zelicapavir, our N-protein inhibitor, both in Phase 2 development. These distinct mechanisms have the potential to be developed as once-daily single agents or in combination for specific patient populations,” added Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. EDP-323 Phase 2a Challenge Study Topline Results This Phase 2a study was a randomized, double-blind, placebo-controlled, human challenge study of 142 healthy adult participants inoculated with RSV. Randomized participants (n=141) received either a once-daily (QD) 600 mg dose of EDP-323 for five days [high dose, n=47], a single 600 mg loading dose on day one followed by a 200 mg once-daily (QD) dose of EDP-323 for four days [low dose, n=47], or placebo for five days [n=47]. The intent-to-treat-infected population (ITT-I) was defined as all randomized participants receiving challenge virus and at least one dose of study drug with confirmed RSV infection. EDP-323 demonstrated a rapid and sustained antiviral effect. A highly statistically significant reduction (p<0.0001) was observed for the primary efficacy endpoint of AUC for viral load as measured by qRT-PCR in the ITT-I population for each of the EDP-323 dosing groups as compared with placebo. Specifically, EDP-323 lowered viral load AUC by 85% in the high dose arm and 87% in the low dose arm compared to placebo. There was no statistically significant difference between the two EDP-323 dosing groups. A highly statistically significant reduction (p<0.0001) was observed for the secondary efficacy endpoint of AUC for infectious viral load as measured by quantitative culture in the ITT-I population for each of the EDP-323 dosing groups, with a reduction in viral culture AUC by 98% in the high dose arm and 97% in the low dose arm compared to placebo. There was no statistically significant difference between the two EDP-323 dosing groups. For the secondary efficacy endpoint of AUC for total symptom score, a highly statistically significant reduction (p<0.0001) was observed in the ITT-I population for each of the EDP-323 dosing groups, with a symptom reduction of 66% in the high dose arm and 78% in the low dose arm compared to placebo. There was no statistically significant difference between the two EDP-323 dosing groups. EDP-323 demonstrated favorable pharmacokinetics, supportive of once-daily dosing. Mean trough plasma concentrations were maintained at 16-fold above the protein-adjusted EC 90 with the low dose, and 35-fold above the protein-adjusted EC 90 with the high dose, for both RSV A and B strains. Overall, EDP-323 demonstrated a favorable safety profile over a 5-day dosing period and through 28 days of follow-up. Adverse events were similar between EDP-323 dosing groups and placebo. There were no serious adverse events, no severe adverse events, and no adverse events leading to treatment discontinuation or study withdrawal. Full data from the study will be presented at a future medical conference or in a peer-reviewed publication. Conference Call and Webcast Information Enanta will host a conference call and webcast today at 8:30 a.m. ET. The live webcast can be accessed at “ Events & Presentations ” in the investors section of Enanta’s website. To participate by phone, please register for the call here . It is recommended that participants register a minimum of 15 minutes before the call. Once registered, participants will receive an email with the dial-in information. The archived webcast will be available on Enanta’s website for approximately 30 days following the event. About EDP-323 EDP-323, a novel, oral, direct-acting antiviral selectively targeting the RSV L-protein, has received Fast Track designation by the U.S. Food and Drug Administration. In a Phase 1 study, EDP-323 was found to be generally safe and well-tolerated in healthy subjects up to 800 mg for up to seven days, with a pharmacokinetic profile supporting once-daily dosing and all doses achieving target exposures. In addition to its Phase 1 profile, EDP-323 is also supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells infected with RSV A and B, and across a range of RSV clinical isolates and various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reductions in lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. About Respiratory Syncytial Virus RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under one year of age in the United States and a significant cause of respiratory illness in older adults and immunocompromised individuals. 1 According to the Centers for Disease Control and Prevention, virtually all children in the United States get an RSV infection by the time they are two years old and one to two out of every 100 children younger than six months of age with an RSV infection may need to be hospitalized. 2 Globally, there are an estimated 33 million cases of RSV annually in children less than five years of age, with about 3 million hospitalized and up to approximately 120,000 dying each year from complications associated with the infection. 3 RSV represents a significant health threat for adults older than 65 years of age, with an estimated 177,000 hospitalizations and 14,000 deaths associated with RSV infections annually in the United States. 4 About Enanta Pharmaceuticals, Inc. Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s research and development programs are currently focused on respiratory syncytial virus (RSV) and chronic spontaneous urticaria (CSU) and the company has previously advanced clinical-stage compounds for SARS-CoV-2 (COVID-19) and chronic hepatitis B virus (HBV) infection. Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET ® (U.S.) and MAVIRET ® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit www.enanta.com for more information. SOURCE: Enanta Pharmaceuticals

Aug. 28, 2024 -- 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 data highlighting the metabolic activation pathway of bemnifosbuvir were published in the peer-reviewed journal, PLOS Biology, in an article titled, “The activation cascade of the broad-spectrum antiviral bemnifosbuvir characterized at atomic resolution.” Bemnifosbuvir, an oral nucleotide RNA-dependent RNA polymerase (RdRp) inhibitor, is in Phase 3 development for the treatment of COVID-19 and in Phase 2 development in combination with ruzasvir, an oral NS5A inhibitor, for the treatment of hepatitis c virus (HCV) infection. Study authors outline the sequences of atomic resolution required to convert bemnifosbuvir (AT-527) into its active 5'-triphosphate, AT-9010. AT-9010 has demonstrated selective inhibition of essential RNA viral enzymes leading to potent antiviral activity. Through the activation pathway to AT-9010, HCV RNA synthesis is halted through RNA chain termination, and SARS-CoV-2 RNA synthesis is halted through targeting of the replicase complex at two distinct sites. “We continue to deepen our scientific knowledge of bemnifosbuvir, our direct-acting antiviral drug candidate derived from Atea’s purine nucleotide prodrug platform,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. “These findings further highlight the sequence of reactions that convert bemnifosbuvir (AT-527) into the active triphosphate metabolite AT-9010, which selectively inhibits key viral enzymes thereby leading to antiviral potency. Insights describing key drug-protein interactions in this publication add to the growing body of evidence supporting bemnifosbuvir’s potential as an effective antiviral therapy for the treatment of COVID-19, HCV and potentially a broad range of RNA viruses.” Data from in vitro testing and clinical trials completed to date has shown that bemnifosbuvir is among just a few antiviral purine nucleotide analogues devoid of significant cellular toxicity. “With these new data, we now have a better understanding of how bemnifosbuvir confers its antiviral activity, as this study identifies the individual enzymes involved in the activation pathway of bemnifosbuvir and clarifies their structural and functional mode of interaction with activation intermediates. This scientific work contributes further to the scientific understanding of bemnifosbuvir and its selective mechanism of action as a direct-acting antiviral,” said Bruno Canard, PhD, lead investigator of the study at Architecture et Fonction des Macromolécules Biologiques, CNRS and Aix-Marseille University. Bemnifosbuvir, an oral nucleotide polymerase inhibitor, targets the SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene which is responsible for both replication and transcription of SARS-CoV-2. Bemnifosbuvir has a unique mechanism of action, with dual targets consisting of chain termination (RdRp) and nucleotityltransferase (NiRAN) inhibition, which have the potential to create a high barrier to resistance. In vitro data confirmed that bemnifosbuvir is active with similar efficacy against all variants of concern and variants of interest that have been tested, including the recent subvariants BA.5, XBB, EG.5.1 and JN.1. The evaluation of bemnifosbuvir for the treatment of COVID-19 has been granted Fast Track designation by the US Food and Drug Administration (FDA). Bemnifosbuvir, an oral HCV NS5B inhibitor, has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated strains (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Across both HCV and COVID-19 programs, bemnifosbuvir has been administered to over 2,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir, an oral HCV NS5A inhibitor, has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,500 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. Ruzasvir’s PK profile supports once-daily dosing. Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Currently, Atea is focused on the development of orally-available antiviral agents for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and hepatitis C virus (HCV). For more information, please visit www.ateapharma.com. The content above comes from the network. if any infringement, please contact us to modify.

Full Enrollment Achieved in Global Phase 2 Hepatitis C Virus (HCV) Study; Complete SVR12 Results Expected 4Q’24 Bemnifosbuvir and Ruzasvir HCV Data Presented at EASL: Support Best-in-Class Potential with High Antiviral Potency, Low Risk of Drug Interaction, Short Treatment Duration and High Barrier to Resistance Results from COVID-19 Global Phase 3 SUNRISE-3 Trial Expected 2H’24 Conference Call at 4:30 pm ET Today BOSTON, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the second quarter ended June 30, 2024, and provided a business update. “The first half of 2024 was marked by strong operational execution and significant clinical progress. We completed patient enrollment in both the global Phase 3 SUNRISE-3 study of bemnifosbuvir for the treatment of COVID-19 and the global Phase 2 study evaluating the combination of bemnifosbuvir and ruzasvir in treatment-naïve, HCV-infected patients,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “Delivering treatment options to address the unmet needs for both COVID-19 and HCV patients remains of critical importance and we look forward to reporting results from both studies this year.” “Today, in the US, the reported annual incidence of approximately 100,000 new chronic HCV infections is outpacing the number of people cured with direct-acting antivirals. Many HCV patients take concomitant medications and in the wake of the opioid epidemic, people with substance abuse disorders and other populations with mental health disorders associated with poor medication adherence, are at the highest risk for HCV. New differentiated HCV therapies that offer low risk of drug-drug interactions combined with short treatment duration are required to address these needs,” continued Dr. Sommadossi. “The bemnifosbuvir and ruzasvir data we recently presented at the EASL Congress demonstrate a potential best-in-class profile and the promise of this combination to address the unmet needs of today’s HCV patient.” COVID-19 Phase 3 SUNRISE-3 Trial Update SUNRISE-3 Trial of Bemnifosbuvir in High-Risk Outpatients with COVID-19: The global, multicenter, randomized, double-blind, placebo-controlled, Phase 3 SUNRISE-3 trial is evaluating bemnifosbuvir or placebo administered concurrently with the locally available standard of care (SOC). SUNRISE-3 exclusively enrolled high-risk outpatients with mild or moderate COVID-19. Patients were randomized 1:1 to receive bemnifosbuvir 550 mg twice-daily (BID) or placebo BID for five days. Topline results from the study are expected in the second half of 2024. The primary endpoint of the SUNRISE-3 trial is all-cause hospitalization or death through Day 29 in the supportive care monotherapy cohort. In addition, secondary endpoints will measure patient outcomes in the trial through Day 60 post-treatment. The trial is comprised of two study populations based on the type of SOC administered at the investigator’s discretion: 1) the "supportive care population," evaluating bemnifosbuvir as monotherapy (primary analysis), and 2) the "combination antiviral population," assessing combination therapy if the SOC includes other compatible antiviral drugs against COVID-19 (secondary analysis). In this study, 2,221 patients were randomized into the supportive care monotherapy cohort and only 74 patients were randomized into the combination cohort, with 77% of all trial patients enrolled in the US. The clear preference by investigators to enroll patients in the monotherapy cohort highlights the continuing unmet medical need for new oral COVID-19 treatment options for high-risk patients. The SUNRISE-3 high risk patient population consists of those aged ≥70 years (regardless of other risk factors), individuals aged ≥55 years with one or more risk factors, those aged ≥50 years with two or more risk factors, and individuals aged ≥18 years with specific risk factors, including immunocompromised conditions, irrespective of COVID-19 vaccination status. COVID-19 Program for Second-Generation Protease Inhibitors: As part of a multi-pronged approach against COVID-19, Atea is engaged in efforts directed to the identification of second-generation protease inhibitors. Activities to select a novel proprietary compound with a differentiated profile are underway. Hepatitis C Virus (HCV) Phase 2 Update Phase 2 HCV Combination Study: In June 2024, Atea completed patient enrollment in the global Phase 2 clinical trial of bemnifosbuvir, an oral nucleotide NS5B polymerase inhibitor, in combination with ruzasvir, an oral NS5A inhibitor, in treatment-naïve, HCV-infected patients either without cirrhosis or with compensated cirrhosis. This study enrolled 275 patients, including the lead-in cohort of 60 patients without cirrhosis. The study is designed to evaluate the safety and efficacy of eight weeks of treatment with the combination consisting of once-daily bemnifosbuvir 550 mg and ruzasvir 180 mg. The primary endpoints of the study are safety and sustained virologic response (SVR) at Week 12 post-treatment (SVR12). Other virologic endpoints include virologic failure, SVR at Week 24 post-treatment (SVR24) and resistance. SVR12 results from all patients in the Phase 2 trial are expected during the fourth quarter of 2024. Positive Data for Bemnifosbuvir and Ruzasvir for Treatment of HCV Presented at European Association of the Study of Liver (EASL) Congress 2024: In June 2024, Atea presented at EASL new clinical data from the lead-in cohort (n=60) of the ongoing Phase 2 study of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV. With an 8-week treatment duration, data from the lead-in cohort of non-cirrhotic patients showed a 97% SVR12 rate, which is the primary efficacy endpoint of the study. Among the 60 patients in the lead-in cohort, two subjects (GT1b and GT2b) experienced post-treatment relapse or failure. Each of these patients had low plasma drug levels and similar viral mutations at both the baseline and 12-weeks post-treatment timepoint, which indicate that the relapse or failure was due to treatment non-adherence rather than viral failure due to resistance. These results also showed a 100% SVR12 rate in participants infected with genotype 3 (n=13), a historically difficult-to-treat genotype of HCV. The combination regimen was well tolerated, with no drug-related serious adverse events or treatment discontinuations. In addition to the clinical trial results at EASL, Atea also presented preclinical data further demonstrating a high barrier to resistance and favorable pharmacokinetics for bemnifosbuvir and a low risk of drug-drug interactions for ruzasvir. Atea has previously reported a low risk of drug-drug interactions for bemnifosbuvir. Selected Fixed Dose Combination Tablet for Phase 3 Program: Atea recently selected the fixed dose combination (FDC) tablet for the Phase 3 program and subsequent commercialization. The selected FDC tablet achieved drug exposure comparable to individually administered bemnifosbuvir and ruzasvir used in Phase 2 and other studies. The selected FDC tablet will decrease the daily pill count from four tablets to two tablets, which is more convenient for patients. In addition, there was no food effect with the FDC tablet in a recent study that showed a high fat, high calorie meal did not affect the exposure of either bemnifosbuvir or ruzasvir. Second Quarter 2024 Financial Results Cash, Cash Equivalents and Marketable Securities: $502.2 million at June 30, 2024 compared to $578.1 million at December 31, 2023. Research and Development Expenses: Research and development expenses increased by $12.6 million from $22.1 million for the three months ended June 30, 2023 to $34.7 million for the three months ended June 30, 2024. The increase was primarily driven by higher external spend related to the advancement of both our Phase 3 COVID-19 SUNRISE-3 clinical trial and our Phase 2 clinical trial of the combination of bemnifosbuvir and ruzasvir for the treatment of HCV. This increase was partially offset by a reduction of approximately $1.0 million in internal costs primarily due to a decrease in consulting and other research and development expenses. General and Administrative Expenses: General and administrative expenses decreased by $1.0 million from $13.2 million for the three months ended June 30, 2023 to $12.2 million for the three months ended June 30, 2024. The net decrease was primarily related to lower professional fees. Interest Income and Other, Net: Interest income and other, net, decreased by $0.7 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023, primarily due to lower investment balances. Income Taxes: Income tax expense of $0.2 million remained unchanged for each of the three months ended June 30, 2024 and June 30, 2023. Condensed Consolidated Statement of Operations and Comprehensive Loss(in thousands, except share and per share amounts)(unaudited) Three Months EndedJune 30, Six Months EndedJune 30, 2024 2023 2024 2023 Operating expenses Research and development$34,696 $22,063 $92,271 $51,017 General and administrative 12,220 13,172 24,451 25,787 Total operating expenses 46,916 35,235 116,722 76,804 Loss from operations (46,916) (35,235) (116,722) (76,804)Interest income and other, net 6,637 7,303 13,505 13,602 Loss before income taxes (40,279) (27,932) (103,217) (63,202)Income tax expense (243) (251) (474) (448)Net loss$(40,522) $(28,183) $(103,691) $(63,650)Other comprehensive loss Unrealized gain (loss) on available-for-sale investments (99) (3) (487) 374 Comprehensive loss$(40,621) $(28,186) $(104,178) $(63,276)Net loss per share - basic and diluted$(0.48) $(0.34) $(1.23) $(0.76)Weighted-average number of common shares - basic and diluted 84,253,700 83,399,377 84,069,646 83,361,398 Selected Condensed Consolidated Balance Sheet Data(in thousands)(unaudited) June 30, 2024 December 31, 2023 Cash, cash equivalents and marketable securities$502,214 $578,106 Working capital(1) 479,750 558,079 Total assets 510,384 594,968 Total liabilities 33,914 39,776 Total stockholder's equity 476,470 555,192 (1) Atea 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 June 30, 2024 for further detail regarding its current assets and liabilities. Conference Call and Webcast Atea will host a conference call and live audio webcast to discuss second quarter 2024 financial results and provide a business update today at 4:30 p.m. ET. To access the live conference call, participants may register here. The live audio webcast of the call will be available under "Events and Presentations" in the Investor Relations section of the Atea Pharmaceuticals website at ir.ateapharma.com. To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start. An archive of the audio webcast will be available on Atea Pharmaceuticals’ website approximately two hours after the conference call and will remain available for at least 90 days following the event. About Bemnifosbuvir for COVID-19 Bemnifosbuvir, an oral nucleotide polymerase inhibitor, targets the SARS-CoV-2 RNA polymerase (nsp12), a highly conserved gene which is responsible for both replication and transcription of SARS-CoV-2. Bemnifosbuvir has a unique mechanism of action, with dual targets consisting of chain termination (RdRp) and nucleotityltransferase (NiRAN) inhibition, which have the potential to create a high barrier to resistance. In vitro data confirmed that bemnifosbuvir is active with similar efficacy against all variants of concern and variants of interest that have been tested, including the recent subvariants BA.5, XBB, EG.5.1 and JN.1. The evaluation of bemnifosbuvir for the treatment of COVID-19 has been granted Fast Track designation by the US Food and Drug Administration (FDA). About Bemnifosbuvir and Ruzasvir for Hepatitis C Virus (HCV) Bemnifosbuvir, an oral HCV NS5B inhibitor, has been shown in in vitro studies to be approximately 10-fold more active than sofosbuvir (SOF) against a panel of laboratory strains and clinical isolates of HCV GT 1–5. In vitro studies have also demonstrated bemnifosbuvir remained fully active against SOF resistance-associated strains (S282T), with up to 58-fold more potency than SOF. The pharmacokinetic (PK) profile of bemnifosbuvir supports once-daily dosing for the treatment of HCV. Across both HCV and COVID-19 programs, bemnifosbuvir has been administered to over 2,200 subjects and has been well-tolerated at doses up to 550 mg for durations up to 12 weeks in healthy subjects and patients. Ruzasvir, an oral HCV NS5A inhibitor, has demonstrated highly potent and pan-genotypic antiviral activity in preclinical (picomolar range) and clinical studies. Ruzasvir has been administered to over 1,500 HCV-infected patients at daily doses of up to 180 mg for 12 weeks and has demonstrated a favorable safety profile. Ruzasvir’s PK profile supports once-daily dosing. About Atea Pharmaceuticals Atea is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging the Company’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Currently, Atea is focused on the development of orally-available antiviral agents for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, and hepatitis C virus (HCV). For more information, please visit www.ateapharma.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to the date and time of the Company’s conference call and audio webcast and the anticipated time of release of clinical trial results from the Company’s COVID-19 and HCV programs. When used herein, words including “expects,” “may,” “will,” “anticipates,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, the important factors discussed and updated from time to time under the caption “Risk Factors” in the reports the Company files with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings each of which are accessible on the SEC’s website at www.sec.gov. These and other important factors 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 the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contacts Jonae BarnesSVP, Investor Relations and Corporate Communications617-818-2985barnes.jonae@ateapharma.com Will O’ConnorPrecision AQ212-362-1200will.oconnor@precisionaq.com