Atea Pharmaceuticals Inc

Our business is subject to numerous risks and uncertainties, including those described in Part I, Item 1A. Risk Factors in this Annual Report on Form 10-K. The principal risks and uncertainties affecting our business include the following:

We have a limited operating history and no history of successfully developing or commercializing any approved antiviral products, which may make it difficult to evaluate the success of our business to date and to assess the prospects for our future viability.

We have incurred significant operating expenses since inception. We expect our expenditures will increase for the foreseeable future. We have no products that have generated any commercial revenue and we may not again achieve or maintain profitability.

We may require substantial additional financing, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development or commercialization efforts.

We may engage in strategic collaborations or other transactions that could disrupt our business, cause dilution to our stockholders, reduce our financial resources, and subject us to other risks.

Our ability to use our net operating loss carryforwards and other tax attributes to offset taxable income may be subject to certain limitations.

Our business is highly dependent on the success of our lead product candidate, the regimen of bemnifosbuvir and ruzasvir for the treatment of HCV infection. If we fail to successfully develop this product candidate or we are unable to obtain regulatory approval or successfully commercialize this or any other product candidates, or are significantly delayed in doing so, our business will be harmed.

The regulatory approval processes of the U.S. Food and Drug Administration (FDA) and comparable foreign regulatory authorities are lengthy, expensive, time-consuming and inherently unpredictable.

Clinical development, including enrollment of patients in clinical trials, is an expensive, lengthy and uncertain process. We may encounter substantial delays and costs in our clinical trials, or may not be able to conduct or complete our clinical trials on the timelines we expect, if at all.

We intend to develop certain of our product candidates in combination with other product candidates that we discover or acquire, which exposes us to additional risks.

Our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their clinical development, prevent their regulatory approval, limit their commercial potential or result in significant negative consequences.

We currently conduct, and may in the future, conduct clinical trials of our product candidates in sites outside the United States (US). The FDA may not accept data from trials conducted in foreign locations.

Interim, topline and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data.

We may not be successful in our efforts to identify and successfully develop additional product candidates.

Risks related to healthcare laws and other legal compliance matters may materially and adversely affect our business and financial results.

Risks related to commercialization may materially and adversely affect our business and financial results.

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Risks related to manufacturing and our dependence on third parties may materially and adversely affect our business and financial results.

Risks related to intellectual property may materially and adversely affect our business and financial results.

We are highly dependent on our management, directors and other key personnel.

Our future success depends on our ability to retain officers, directors and key employee and to attract, retain and motivate qualified personnel.

Our business and operations may suffer in the event of system failures, security breaches, deficiencies or intrusions which could materially affect our results.

We or the third parties whom we depend upon may be adversely affected by natural disasters or other unforeseen events resulting in business interruptions and our business continuity and disaster recovery plans may not adequately protect us from such business interruptions.

Increased scrutiny of, and evolving expectations for, environmental, social, and governance initiatives could increase our costs, harm our reputation, or otherwise adversely impact our business and financial results.

Litigation against us could be costly and time-consuming to defend and could result in additional liabilities.

Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and stock price.

Risks related to our common stock may materially and adversely affect our stock price.

If we fail to maintain effective internal control over financial reporting and effective disclosure controls and procedures, we may not be able to accurately report our financial results in a timely manner or prevent fraud, which may adversely affect investor confidence in our cCompany.

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PART I