Atea Pharmaceuticals, Inc. · NASDAQ:AVIR
Atea Pharmaceuticals — JP Morgan Healthcare Conference 2022
28 slides from Atea Pharmaceuticals's conference presentation, Jan 10, 2022
Slide 1: JP Morgan Healthcare Conference
June 2020 JP Morgan Healthcare Conference January 10, 2022 Exhibit 99.1
Slide 2: Forward-Looking Statements
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,
Slide 3: Proprietary Platform Generates Deep Antiviral Pipeline
ssRNA VIRUS THERAPEUTIC INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 Coronaviridae COVID-19 Bemnifosbuvir (AT-527) Nucleotide* COVID-19 Combination with protease inhibitors Bemnifosbuvir Nucleotide Flaviviridae Hepatitis C (HCV) Bemnifosbuvir Nucleotide Hepatitis C (HCV) Dengue Virus Ruzasvir** (N
Slide 4: Comprehensive Approach to COVID-19 Bemnifosbuvir
Comprehensive Approach to COVID-19 Bemnifosbuvir
Slide 5: Vision for Bemnifosbuvir in COVID-19: Backbone of First Combination Therapy
Vision for Bemnifosbuvir in COVID-19: Backbone of First Combination Therapy Bemnifosbuvir (AT-527) Addresses Key Challenges of COVID-19 Oral nucleotide with antiviral activity across SARS-CoV-2 variants of concern/interest Targets viral RNA polymerase, highly conserved enzyme critical to viral repli
Slide 6: COVID-19 Persistent Viral Disease - Transitioning to Endemic with Pandemic Surges
COVID-19 Persistent Viral Disease - Transitioning to Endemic with Pandemic Surges 6 COVID-19 Over 6,000 variants sequenced New variants associated with increased transmissibility, neutralization resistance and disease severity Omicron variant > 30 mutations to viral spike protein Extremely contagiou
Slide 7: AT-511 Active In Vitro Against all SARS-CoV-2 Variants
7 AT-511 (free base of bemnifosbuvir) Active In Vitro Against all SARS-CoV-2 Variants Variant Lineage Strain Relative Potency* AT-511 EC90 [Variants/USA-WA-1] Original A USA-WA1/2020 1 Alpha B.1.1.7 England/ 204820464/2020 2.8 (n=3) Gamma P.1 Japan/TY7-503/2021 3.2 (n=3) Epsilon B.1.427 USA/CA/ VRLC
Slide 8: Bemnifosbuvir – Nucleos(t)ide Polymerase of Choice for Combination Therapy
8 In vitro combination studies with protease inhibitors are being initiated to explore antiviral synergy and address potential emergence of resistance Bemnifosbuvir – Nucleos(t)ide Polymerase of Choice for Potential Combination Therapy with Protease Inhibitor for COVID-19 Bemnifosbuvir Molnupiravir
Slide 9: Clinical Development Update and Plan Bemnifosbuvir
9 Clinical Development Update and Plan Bemnifosbuvir
Slide 10: Bemnifosbuvir Safety and Antiviral Activity Summary
Bemnifosbuvir Safety and Antiviral Activity Summary Clinical Development Highlights Accomplished To-Date Phase 1 studies demonstrated trough levels exceeding EC90 in >75% of patients Bronchoalveolar lavage study confirmed drug levels approximating plasma levels achieved in airways Rapid and sustaine
Slide 11: Bemnifosbuvir Clinical Development Program for COVID-19
Bemnifosbuvir Clinical Development Program for COVID-19 11 TRIAL DESCRIPTION STATUS Phase 1 Healthy Volunteers PK, tolerability with optimized formulation at doses up to 1100 mg BID Ongoing Phase 2 Monotherapy - Hospitalized High Risk Patients with Moderate COVID-19 Safety, tolerability, and virolog
Slide 12: Phase 2 Hospitalized Study Interim Results
Bemnifosbuvir Global Phase 2 Hospitalized Study Interim Results for COVID-19: Rapid and Sustained Decrease in Viral Load in All Evaluable Patients (High Risk, Unvaccinated) 12 Bemnifosbuvir 500 mg BID Day 2 -0.7 log10 reduction vs. placebo Viral Load Decrease from Baseline Bemnifosbuvir Placebo COVI
Slide 13: MOONSONG Exploratory Analyses: Infectious Virus in High-Risk Patients
13 Bemnifosbuvir Phase 2 MOONSONG Exploratory Analyses Infectious Virus: High-Risk Patients Potent and Rapid Antiviral Activity Suggesting Dose Response between Cohort A and B Infectious Virus Titer Change from Baseline* Cohort A (550 mg BID ) High Risk Subgroup** *Baseline adjusted (ANCOVA) conside
Slide 14: Vision for Bemnifosbuvir in COVID-19: Nucleotide of Choice
Vision for Bemnifosbuvir in COVID-19: Nucleotide of Choice First Combination Therapy Planned Phase 2 outpatient trial builds upon positive findings in high-risk patients in previous Phase 2 trials Up to 200 high-risk outpatients with mild-moderate COVID-19 Utilizing a formulation with rapid dissolut
Slide 15: Hepatitis C: Global Strategy
Hepatitis C: Global Strategy
Slide 16: HCV Mortality Increasing Despite Effective DAA Combinations
16 HCV-related mortality incidence has increased even with effective DAA combinations Approx. 70% of long-term IV drug users have HCV in US Convenient 8 weeks or shorter treatments are needed for new wave of early/acute HCV infection Best-in-class combination has potential for > $1B Fueled by the Op
Slide 17: Ruzasvir – Oral, Highly Potent Pan-genotypic NS5A Inhibitor
17 Exclusive worldwide license from Merck License includes all human indications Next generation pan-genotypic potent antiviral activity in picomolar range in in vitro studies confirmed with > 3 log10 viral load decline in HCV-infected patients as monotherapy Demonstrated substantial synergy with be
Slide 18: Bemnifosbuvir Monotherapy Demonstrated Unprecedented Antiviral Activity
18 4.5 log10 ± 0.3 IU/ml in GT3-infected patients 4.6 log10 ± 0.5 IU/ml in patients with compensated cirrhosis (GT1,2,3) Bemnifosbuvir as Monotherapy Demonstrated Unprecedented Antiviral Activity with Favorable Safety Profile in Phase 1 and Phase 2 Clinical Trials Last Dose Bemnifosbuvir 550 mg QD D
Slide 19: Bemnifosbuvir + Ruzasvir: Combination-Ready Assets
19 Bemnifosbuvir + Ruzasvir: Phase 2 combination-ready assets Phase 2 combination program expected to initiate 2H 2022 to evaluate: Convenient and short 8-week duration (potentially shorter for early/acute infections) Acute and chronic HCV infection Patients with compensated and decompensated liver
Slide 20: Clinical Proof-of-Concept Program for Dengue Fever AT-752
20 Clinical Proof-of-Concept Program for Dengue Fever AT-752
Slide 21: Dengue Fever: High Mortality and High Unmet Medical Need
Painful, debilitating mosquito-born disease Caused by 4 serotypes Symptoms 3-14 days post-infection with high fever 2-7 days Dengue Fever: High Mortality and High Unmet Medical Need 21 People live in high-risk areas* strong efficacy in an dengue range currently expanding Estimated infected annually
Slide 22: Successful Completion of AT-752 Phase 1 SAD and MAD Cohorts
Successful Completion of AT-752 Phase 1 Study 1 SAD and 3 MAD Cohorts 22 Objectives: Safety and PK (with embedded food effect) Part 1: Single ascending dose cohort Part 2: Multiple dose QD/BID/TID Inclusion Criteria: healthy volunteers, sequential dose-escalation Country: Australia AT-752 Dose MAD R
Slide 23: AT-752 Pharmacokinetic Results Demonstrate Effective Drug Exposure
AT-752 Phase 1 Pharmacokinetic Results Demonstrate Effective Drug Exposure for Inhibiting Dengue Virus Replication 23 Target EC90 750 mg TID Rapidly Achieved Plasma Levels of Surrogate Metabolite Above in vitro EC90 DENGUE
Slide 24: AT-752 Human Challenge Infection Model
24 Population: Healthy subjects, 18-55 years Location: US Design: Day 1: 12 subjects randomized 3:1 administered oral AT-752 or matching placebo Day 2: Challenged with 0.5 mL DENV-1-LVHC (6.5 x 103 PFU/mL) AT-752 Human Challenge Infection Model DENGUE Endpoints: Mean quantitative viral load (peak, d
Slide 25: AT-752 Global Proof-of-Concept Treatment Study Design
AT-752 Phase 2 Global Proof-of-Concept Treatment Study Design 25 AT-752 Dose B Randomization N=Up to 60 Placebo Double-blind oral administration: 5 days 1H / 22 Initiation AT-752 Dose A AT-752 Dose C Objectives: Antiviral activity, safety, PK Primary endpoint: Change in dengue virus viral load from
Slide 26: Closing Remarks
Closing Remarks 26
Slide 27: Multiple Upcoming Value-Driving Milestones
Multiple Upcoming Value-Driving Milestones Phase 2 data: late 2022 Initiate Phase 2/3 combo trial + protease inhibitor: late 2022 Initiate bemnifosbuvir + Ruzasvir Phase 2 combo trial: late 2022 Initiate proof-of-concept program: initial data late 2022 Cash runway through 2025 COVID-19 Hepatitis C D
Slide 28: Atea Pharmaceuticals contact details
June 2020 125 Summer Street Boston MA USA 02110 857 284 8891 www.ateapharma.com
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