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 other future conditions including without limitation the future of the COVID-19 and HCV landscapes and related commercial market opportunities. All statements other than statements of historical facts contained in this presentation are forward-looking statements, including statements by Atea Pharmaceuticals, Inc. (the "Company") regarding future results of operations and financial position, including our anticipated cash runway; business strategy; current and prospective product candidates; anticipated milestone events; potential benefits of our product candidates and market opportunity; clinical trials, including, without limitation, anticipated initiation, enrollment, regulatory submission and data readout timelines; preclinical activities; product approvals; manufacturing availability; degree of market acceptance of any products that may be approved; research and development costs; current and prospective collaborations; and prospects and opportunities for investors. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions.
The information in this presentation, including without limitation the forward-looking statements contained herein, represent our views as of the date of this presentation. 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 anticipated results, performance or achievements expressed or implied by the forward-looking statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control, our ability to manufacture sufficient commercial product, competition from authorized and approved treatments for COVID-19 and hepatitis C, risks related to the continued evolution of COVID-19, and other important risks and uncertainties that are described in our Annual Report on Form 10-K filed for the year ended December 31, 2023 and our most recent quarterly report on Form 10-Q filed with the Securities and Exchange Commission ("SEC") and our other filings with the SEC. New risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you are cautioned not to place undue reliance on these forward-looking statements.
Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Industry Information
Market data and industry information used throughout this presentation are based on management's knowledge of the industry and the good faith estimates of management. We also relied, to the extent available, upon management's review of independent industry surveys and publications and other publicly available information prepared by a number of third-party sources. All of the market data and industry information used in this presentation involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Although we believe that these sources are reliable, we cannot guarantee the accuracy or completeness of this information, and we have not independently verified this information. While we believe the estimated market position, market opportunity and market size information included in this presentation are generally reliable, such information, which is derived in part from management's estimates and beliefs, is inherently uncertain and imprecise. No representations or warranties are made by the Company or any of its affiliates as to the accuracy of any such statements or projections. Projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate are necessarily subject to a high degree of uncertainty and risk due
to a variety of factors, including those described above. These and other factors could cause results to differ materially from those expressed in our estimates and beliefs and in the estimates prepared by independent parties.
2
Significant Near-term Clinical Milestones in 2024
Fully Funded Through Key Inflection Points
COVID-19 - Global Phase 3 SUNRISE-3 Trial
Full enrollment achieved | Topline |
with 2,221 patients in | |
results | |
monotherapy cohort, 74 | |
2H'24 | |
in combination cohort | |
Mar'24 |
2024
Reported 98% SVR4 rate | Preclinical & | Fixed | Ph 2 complete | |
new Ph 2 | dose tablet | |||
for lead-in cohort of 60 | SVR12 results | |||
patients & resumed | efficacy data | selection | 2H'24 | |
HCV | presentations at | Mid'24 | ||
enrollment Jan'24 | ||||
EASL Jun'24 |
HCV - Global Phase 2 Study
NDA submission target
YE'24
2025
Ph 3 Initiation target
YE'24
$541.5 M | Cash, cash equivalents & marketable securities at 3/31/24 |
Cash runway now anticipated into 2027 |
3
HEPATITIS C
Program Update:
Potential Best-in-Class
Pan-Genotypic Regimen
- Phase 2 Open Label Study of Bemnifosbuvir + Ruzasvir
HCV
Continues to be a healthcare crisis in US
Recognized ongoing unmet needs by US healthcare providers
UNMET MEDICAL NEED in US:
>2M estimated to have HCV
New chronic HCV cases (~100,000) annually exceed cures
Best-in-Class Target Profile - Bemnifosbuvir + Ruzasvir
Bemnifosbuvir is the most potent nucleotide inhibitor for HCV1 and ruzasvir is a highly potent NS5A inhibitor2
- Short 8-week treatment with lower daily pill burden
- Potential for fewer side effects, low risk for drug-drug interactions and no food effect
- Protease inhibitor-free treatment
Global Market Opportunity:
>$3B | Primarily | No |
2 | competitors | |
net sales in | product | in clinical |
2023 | development | |
market | ||
5 | 1. | PLoS ONE 15(1):e0227104 https://doi.org/10.1371/journal.pone.0227104 |
2. | Journal of Viral Hepatitis, 2019, September:26 (9); 1127-1138. |
HEPATITIS C
Bemnifosbuvir (BEM) + Ruzasvir (RZR) Target Product Profile
Profile | BEM+RZR | MAVYRET® | EPCLUSA® | |
Non-Cirrhotic | 8 Weeks | 8 Weeks | 12 Weeks | |
Treatment Duration | Compensated Cirrhosis | 8 Weeks | 8 Weeks | 12 Weeks |
Decompensated Cirrhosis | 12 Weeks | 12 Weeks + | ||
(No RBV) | RBV | |||
Short Duration
Protease-Inhibitor Free
Low Potential for Drug-Drug Interactions
No Food Effect
- RBV= Ribavirin
HEPATITIS C
US HCV Market: Epclusa® & Mavyret®
Potential US HCV |
Market Value |
2022 | 2023 | |
# of Patients (NRxs) Treated1 | 93,452 | 98,412 |
Total US HCV Market | $1,599M | $1,518M |
Net Revenues2 | ||
Net Revenues Per | $17,110 | $15,425 |
Patient Treated | ||
Epclusa®* NRx Market Share1 | 53% | 54% |
Mavyret® NRx Market Share1 | 43% | 42% |
Market demand grew ~5% 2023
2023
$1.5B
US Net Revenues
for DAA
98,412
- of US Patients Treated (NRxs)
Stable
market share
Treatment of all | >$20B |
current chronic | |
HCV patients | Potential Market Value** |
>2M | |
Chronic US HCV | |
Prevalence |
FUTURE DRIVERS
- US government initiatives
- Optimal product profile
- Removal of HCV prescribing barriers by payors
*Epclusa includes both brand and authorized generics | ** Assumes treatment of all currently chronically infected HCV |
patients of 2.2M at $10,000 Net Revenue/Patient | |
77
1. IQVIA NPA Data 2. Net Revenues from Gilead and Abbvie's full-year 2023 earnings press release
HEPATITIS C
Phase 2 Open Label Study of Bemnifosbuvir + Ruzasvir in HCV Patients
Study Design: Open label combination
N= up to 280: including lead-in cohort
Patient Population:
- HCV-infectedpatients, including compensated cirrhosis
- Direct-actingantiviral naïve
- All genotypes
60 Patient Lead-in Cohort:
• Safety and tolerability
• Sustained virologic response (SVR) at Week 4 post-treatment (SVR4)
Bemnifosbuvir (BEM) 550 mg QD | Enrollment |
Ruzasvir (RZR) 180 mg QD | Ongoing |
8 weeks dosing w/combination
Primary Endpoints:
- SVR at Week 12 post-treatment (SVR12)
- Safety
Other Endpoints:
- Virologic failure
- SVR at Week 24 post-treatment (SVR24)
- Resistance
8
HEPATITIS C
New Data: Final Results 98% SVR4 Post-Treatment
Phase 2 Open Label Study of Bemnifosbuvir + Ruzasvir Lead-in Cohort
100
90 | 100% | 98% | ||
90% | ||||
80 | ||||
(%) | 70 | |||
<> | 60 | |||
50 | ||||
Patients | 40 | |||
30 | ||||
20 | ||||
10 | ||||
54/60 | 60/60 | 58/59* | ||
0 | ||||
Wk 4 | Wk 8 | SVR4 | ||
Study Visit |
LLOQ=Lower limit of quantification *Does not include 1 subject who did not attend the SVR4 visit.
BEM + RZR with short 8-week treatment
Final results for lead-in cohort: 98% SVR4
- 1 genotype 2 subject with poor
adherence did not achieve SVR4
(lower pill consumption and inadequate PK drug levels)
9
HEPATITIS C
On-Treatment Viral Kinetics - Individual Patient Data (n=60)
Phase 2 Open Label Study of Bemnifosbuvir + Ruzasvir Lead-in Cohort
• Regardless of baseline viral load, all patients (n=60) near or below LLOQ by Week 4
• BEM + RZR viral kinetics compare favorably to Mavyret1, the only approved 8-week treatment for HCV
• Very rapid kinetics across genotypes support an 8-week regimen
LLOQ=Lower limit of quantification
1. Sarrazin et.al; Presented at ID Week 2018
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Atea Pharmaceuticals Inc. published this content on 14 May 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 14 May 2024 20:16:21 UTC.