Atea Pharmaceuticals, Inc. · NASDAQ:AVIR
Atea Pharmaceuticals — Q2 2024 Earnings Presentation
30 slides from Atea Pharmaceuticals's earnings presentation, Aug 7, 2024
Slide 1: Second Quarter Financial and Business Update
Second Quarter Financial and Business Update August 7, 2024 NASDAQ: AVIR June 2020
Slide 2: Disclaimers
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 curr
Slide 3: Achieved and Upcoming Significant Clinical Milestones in 2024
Achieved and Upcoming Significant Clinical Milestones in 2024 Fully Funded Through Key Inflection Points COVID-19 – Global Phase 3 SUNRISE-3 Trial ü Full enrollment achieved NDA with 2,221 patients in Topline results submission monotherapy cohort, 74 in target combination cohort Mar’24 2H’24 ~YE’24
Slide 4: Program Update: Potential Best-in-Class Pan-Genotypic Regimen
HEPATITIS C Program Update: Potential Best-in-Class Pan-Genotypic Regimen • Phase 2 Open Label Study of Bemnifosbuvir + Ruzasvir
Slide 5: Best-in-Class Target Profile - Bemnifosbuvir + Ruzasvir
Best-in-Class Target Profile - Bemnifosbuvir + Ruzasvir HCV Bemnifosbuvir is the most potent nucleotide inhibitor for HCV2 Continues to be a and ruzasvir is a highly potent NS5A inhibitor3 healthcare crisis in US Recognized ongoing unmet • Potential for fewer side effects, low risk for drug-drug int
Slide 6: US HCV Market: Epclusa & Mavyret
HEPATITIS C US HCV Market: Epclusa® & Mavyret® Potential US HCV Market Value 2022 2023 Market demand Treatment of all grew ~5% 2023 current chronic HCV patients >$20B+ # of Patients (NRxs) Treated 1 93,452 98,412 Potential Market Value3 2023 ~2-4M 4 Total US HCV Market Net Revenues 2 $1,599M $1,518M
Slide 7: Profile of Today's HCV-Infected Patient
HEPATITIS C Profile of Today’s HCV-Infected Patient Predominately Younger Patient Population (30-39 yrs old)1, Newly Infected1 Therefore <10% Cirrhotic2 Unmet Need Due to DDIs Unmet Need for Convenient Therapy High proportion of current HCV- Populations at highest risk for infected patients take con
Slide 8: Bemnifosbuvir + Ruzasvir Target Product Profile
HEPATITIS C Bemnifosbuvir (BEM) + Ruzasvir (RZR) Target Product Profile BEM + RZR Profile Addresses Unmet Needs of Today’s HCV-Infected Patients Profile BEM+RZR MAVYRET® EPCLUSA® Non-Cirrhotic 8 Weeks 8 Weeks 12 Weeks Treatment Duration Compensated Cirrhosis 8 Weeks 8 Weeks 12 Weeks 12 Weeks 12 Week
Slide 9: New Fixed Dose Combination Tablet Achieved Comparable Drug Exposure
HEPATITIS C New Fixed Dose Combination (FDC) Tablet Achieved Drug Exposure Comparable to Individually Administered BEM + RZR Used in Phase 2 & Other Studies FDC Tablet for Phase 3 Program and Subsequent Commercialization AT-273 is the plasma surrogate marker for active intracellular triphosphate met
Slide 10: Phase 2 Open Label Study of BEM + RZR in HCV Patients
HEPATITIS C Phase 2 Open Label Study of BEM + RZR in HCV Patients BEM 550 mg QD Enrollment Study Design: Open label combination Achieved RZR 180 mg QD June 2024 N= 275 patients: including lead-in cohort 8 weeks dosing w/combination Patient Population: • HCV-infected patients, including Primary Endpo
Slide 11: On-treatment Viral Kinetics – Individual Patient Data (n=60)
HEPATITIS C On-treatment Viral Kinetics – Individual Patient Data (n=60) Phase 2 Open Label Study of BEM + RZR Lead-in Cohort • Rapid viral reduction in all patients within the first week HCV RNA, log10 IU/mL regardless of baseline viremia and genotype • Viral load in all patients near or below LLOQ
Slide 12: HCV RNA Qualitative Results – All Genotypes (N=60)
HEPATITIS C HCV RNA Qualitative Results – All Genotypes (N=60) Phase 2 Open Label Study of BEM + RZR Lead-in Cohort • 97% SVR12 rate in lead-in cohort • 2 subjects (GT1b and GT2b) with post- treatment relapse • Low plasma drug levels and similar viral mutations at baseline and 12-weeks post- treatme
Slide 13: HCV RNA Qualitative Results – Genotypes 1 and 3
HEPATITIS C HCV RNA Qualitative Results – Genotypes 1 and 3 Phase 2 Open Label Study of BEM + RZR Lead-in Cohort • High SVR12 rates in historically difficult to treat HCV patients • Similar viral kinetics in GT1 and GT3 13 LLOQ=Lower limit of quantification
Slide 14: Post-Treatment Relapse – GT1b-infected Patient
HEPATITIS C Post-Treatment Relapse – GT1b-infected Patient Plasma drug level, Phase 2 Open Label Study of BEM + RZR Lead-in Cohort ng/mL DAY AT-273 RZR 1 BLQ BLQ 8 161 173 15 246 263 29 235 248 43 45.7 28.1 57 33.2 28.3 AT-273 is the surrogate for the BEM active triphosphate • Low plasma drug levels
Slide 15: Post-Treatment Relapse – GT2b-infected Patient
HEPATITIS C Post-Treatment Relapse – GT2b-infected Patient Plasma drug level, Phase 2 Open Label Study of BEM + RZR Lead-in Cohort ng/mL DAY AT-273 RZR 1 BLQ BLQ 8 42.6 70.9 15 61.36 42.2 29 46.6 53.3 43 47.4 27.6 57 24.4 24.4 AT-273 is the surrogate for the BEM active triphosphate • Low plasma drug
Slide 16: Individual Profiles – Lower Exposures Achieving SVR12
HEPATITIS C Individual Profiles – Lower Exposures Achieving SVR12 Phase 2 Open Label Study of BEM + RZR Lead-in Cohort EOT SVR4 SVR12 EOT SVR4 SVR12 8 8 GT1a patient: pill counts suggest 75% compliance 600 600 GT1b patient: pill counts suggest 100% while there were no drug levels Day 29+ compliance
Slide 17: Open Label Phase 2 Lead-in Cohort Results (n=60)
HEPATITIS C Open Label Phase 2 Lead-in Cohort Results (n=60) Phase 2 Open Label Study of BEM + RZR Lead-in Cohort Safety Summary • All patients (n=60) completed the 8-week treatment period • Bemnifosbuvir + ruzasvir was generally safe and well tolerated • No drug-related SAEs or premature treatment
Slide 18: Strong Operational Execution, Preparing for Global Phase 3 Program
HEPATITIS C Strong Operational Execution, Preparing for Global Phase 3 Program BEM + RZR: Potential Best-in-Class Pan-genotypic Regimen • Achieved patient enrollment June 2024 (n=275) • Selected fixed dose combination tablet • Phase 2 complete SVR12 results expected Q4’24 HCV unmet medical needs • P
Slide 19: Bemnifosbuvir Phase 3 Program
COVID-19 Bemnifosbuvir Phase 3 Program • COVID-19 Unmet Medical Need • Global Phase 3 SUNRISE-3 Trial
Slide 20: COVID-19 Variants Continue to Rapidly Emerge Creating Waves of Infection
COVID-19 COVID-19 Variants Continue to Rapidly Emerge Creating Waves of Infection Early Summer Wave Driven by KP Variants and Closely Related LB.1 20 CDC: https://covid.cdc.gov/covid-data-tracker/#variant-summary
Slide 21: COVID-19: Bemnifosbuvir Target Profile and Market Opportunity
Bemnifosbuvir Target Profile: COVID-19 • Low risk of drug-drug interactions Continuing Threat, • Generally safe and well-tolerated Particularly for Those Vulnerable to Severe Disease • Distinct MOA with high barrier to resistance New, Safe and Well-Tolerated In the MORNINGSKY* trial, risk of hospita
Slide 22: SUNRISE-3: Global Phase 3 Trial in High-Risk COVID-19 Outpatients
COVID-19 SUNRISE-3: Global Phase 3 Trial in High-Risk COVID-19 Outpatients Bemnifosbuvir – U.S. Fast Track Designation for COVID-19 Inclusion Criteria: High-risk outpatients Bemnifosbuvir 550 mg BID + SOC Enrollment with mild or moderate COVID-19, Completed regardless of vaccination status; symptom
Slide 23: Strong Operational Execution of Global Phase 3 SUNRISE-3 Trial
COVID-19 Strong Operational Execution of Global Phase 3 SUNRISE-3 Trial Only Current Phase 3 Program in High-Risk Patients with Hospitalization as Primary Endpoint • SUNRISE-3 enrolled ahead of guidance • Enrolled 2,221 patients in monotherapy Unmet Medical Need cohort and 74 patients on combination
Slide 24: US TRx Demand for COVID-19 Oral Antivirals Correlates with Infections
COVID-19 US TRx Demand for COVID-19 Oral Antivirals Correlates with Infections US Demand: Monthly COVID-19 Oral Antiviral Prescriptions Dispensed (thousands) 1,200 32% increase in 130 June 2024 TRx 1,000 vs June 2023 121 101 97 correlates with 800 93 early summer wave Thousands 88 72 79 600 64 65 1,
Slide 25: Financial Summary
Financial Summary 25
Slide 26: Financial Update Second Quarter 2024
Financial Update Second Quarter 2024 26
Slide 27: Financial Update Second Quarter 2024
Financial Update Second Quarter 2024 27
Slide 28: Closing Remarks
Closing Remarks Corporate Presentation NASDAQ: AVIR June 2020
Slide 29: Focused Antiviral Pipeline, Strong Operational Execution Across Programs
Focused Antiviral Pipeline, Strong Operational Execution Across Programs Key Clinical Data Expected in 2024: Phase 3 SUNRISE-3 Results and Complete Phase 2 HCV Results PROGRAM THERAPEUTIC INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 MAJOR MILESTONES 2024 Coronaviridae COVID-19 Full enrollment achi
Slide 30: June 2020
225 Franklin Street Suite 2100 Boston MA USA 02110 www.ateapharma.com June 2020