10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2024

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from _______________ to _______________

Commission File Number: 001-39661

 

Atea Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

46-0574869

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

225 Franklin Street, Suite 2100

Boston, MA

02110

(Address of principal executive offices)

(Zip Code)

 

(857) 284-8891

(Registrant’s telephone number, including area code)

 

 

(Former name, former address and former fiscal year, if changed since last report)

 

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common Stock, $0.001 par value per share

 

AVIR

 

The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

Accelerated filer

 

 

 

 

Non-accelerated filer

Smaller reporting company

 

 

 

 

 

 

 

 

 

 

 

Emerging growth company

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No

As of August 7, 2024, the registrant had 84,422,000 shares of common stock, $0.001 par value per share, outstanding.

 

 


 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This Quarterly Report on Form 10-Q contains forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. 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 development timelines and results and other future conditions. The words “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” "objective," "on track," “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, among other things, statements about:

our expectations relating to clinical trials for our product candidates, including projected costs, study designs and the timing for initiation, recruitment, completion, and reporting interim, top-line and final data;
the potential therapeutic benefits of our product candidates and the potential indications and market opportunities therefor;
the potential of bemnifosbuvir to retain antiviral activity against circulating COVID-19 variants of concern and to treat Coronavirus disease 2019 ("COVID-19");
the safety profile and related adverse events of our product candidates;
our plans to research, develop and commercialize our current and future product candidates;
the potential benefits of any future collaboration we may enter into;
the timing of and our ability to apply for, and if successful, obtain and maintain regulatory approvals for our product candidates;
the rate and degree of market acceptance and clinical utility of any products for which we may receive marketing approval;
our manufacturing and commercialization capabilities and strategy;
our estimates regarding future revenue, expenses and results of operations;
the progress of, timing of and amount of expenses associated with our research, development and commercialization activities;
our future financial position, capital requirements, cash runway, needs for additional financing and the availability of such financing;
our business strategy;
developments relating to our industry and our competitors, including competing treatments and vaccines for diseases we are treating;
our expectations regarding federal, state and foreign laws and regulations;
our ability to attract, motivate, and retain key personnel; and
the impact on our business as COVID-19 continues to evolve.

These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate. 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 future results, performance or achievements expressed or implied by the forward-looking statements. Factors that may cause actual results to differ materially from current expectations include the initiation, execution and completion of clinical trials, uncertainties surrounding the timing of availability of data from our clinical trials, ongoing discussions with and actions by regulatory authorities, our development activities and those other factors we discuss in Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q. You should read these risk factors and the other cautionary

i


 

statements made in this report as being applicable to all related forward-looking statements wherever they appear in this report. The risk factors are not exhaustive and other sections of this report may include additional factors which could adversely impact our business and financial performance.

Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Preliminary and interim results from any trial and results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements.

Given these uncertainties, you should not rely on these forward-looking statements as predictions of future events. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

As used in this Quarterly Report on Form 10-Q, unless otherwise specified or the context otherwise requires, the terms “we,” “our,” “us,” and the “Company” refer to Atea Pharmaceuticals, Inc. and its subsidiary. All brand names or trademarks appearing in this Quarterly Report on Form 10-Q are the property of their respective owners.

ii


 

SUMMARY RISK FACTORS

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

There is significant uncertainty around our development of bemnifosbuvir as a potential treatment for COVID-19.
We are expending significant resources to develop bemnifosbuvir for the treatment of COVID-19 and to develop the combination of bemnifosbuvir and ruzasvir for the treatment of Hepatitis C virus (“HCV”) and in anticipation of potential commercialization of these product candidates. We may not be able to recover these resources if these product candidates are not approved for the treatment of the respective indication for which they are being developed, we are not successful at commercializing these product candidates or in the case of the development of bemnifosbuvir for the treatment of COVID-19, bemnifosbuvir is rendered inferior or obsolete due to rapid changes in COVID-19 epidemiology as a result of the emergence of new SARS-CoV-2 variants or subvariants.
If approved, each of our product candidates will face significant competition from other treatments, including direct acting antivirals, that are currently marketed, and in the instance of COVID-19, it could include drug candidates that are currently in development.
Our business, operations and financial results may be materially and adversely affected by the continuing evolution of COVID-19.
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 will 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.
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 most advanced product candidates. If we fail to successfully develop bemnifosbuvir for the treatment of COVID-19 or the combination of bemnifosbuvir and ruzasvir for the treatment of HCV or we are unable to obtain regulatory approval or successfully commercialize any of our 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.

iii


 

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.
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.
We have only a limited number of employees, which may be inadequate to manage and operate our business.
We may need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
Our business and operations may suffer in the event of system failures, security breaches, deficiencies or intrusions which could materially affect our results.
We may engage in acquisitions or strategic collaborations that could disrupt our business, cause dilution to our stockholders, reduce our financial resources, cause us to incur debt or assume contingent liabilities, and subject us to other risks.
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 attention to, and evolving expectations for, environmental, social, and governance (“ESG”) initiatives could increase our costs, harm our reputation, or otherwise adversely impact our business.
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 company.

 

iv


 

Table of Contents

 

Page

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

i

SUMMARY RISK FACTORS

iii

 

 

 

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

Condensed Consolidated Statements of Stockholders’ Equity

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Condensed Consolidated Financial Statements

5

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

14

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

23

Item 4.

Controls and Procedures

23

 

 

 

PART II.

OTHER INFORMATION

24

Item 1.

Legal Proceedings

24

Item 1A.

Risk Factors

24

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

87

Item 5.

Other Information

88

Item 6.

Exhibits

89

SIGNATURES

90

 

v


 

PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

Atea Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share amounts)

(Unaudited)

 

 

 

June 30,
2024

 

 

December 31,
2023

 

Assets

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

 

$

243,394

 

 

$

143,823

 

Marketable securities

 

 

258,820

 

 

 

434,283

 

Prepaid expenses and other current assets

 

 

4,155

 

 

 

12,349

 

Total current assets

 

 

506,369

 

 

 

590,455

 

Property and equipment, net

 

 

1,081

 

 

 

1,289

 

Other assets

 

 

1,396

 

 

 

1,396

 

Operating lease right-of-use assets, net

 

 

1,538

 

 

 

1,828

 

Total assets

 

$

510,384

 

 

$

594,968

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable

 

$

5,470

 

 

$

4,252

 

Accrued expenses and other current liabilities

 

 

20,369

 

 

 

27,364

 

Current portion of operating lease liabilities

 

 

780

 

 

 

760

 

Total current liabilities

 

 

26,619

 

 

 

32,376

 

Operating lease liabilities

 

 

1,245

 

 

 

1,642

 

Income taxes payable

 

 

6,050

 

 

 

5,758

 

Total liabilities

 

 

33,914

 

 

 

39,776

 

Commitments and contingencies (see Note 12)

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Preferred stock, $0.001 par value per share; 10,000,000 shares
   authorized;
no shares issued and outstanding

 

 

 

 

 

 

Common stock, $0.001 par value; 300,000,000 shares authorized;
84,422,000 and 83,435,513 shares issued and outstanding
as of June 30, 2024 and December 31, 2023, respectively

 

 

84

 

 

 

83

 

Additional paid-in capital

 

 

776,192

 

 

 

750,737

 

Accumulated other comprehensive gain (loss)

 

 

(280

)

 

 

207

 

Accumulated deficit

 

 

(299,526

)

 

 

(195,835

)

Total stockholders’ equity

 

 

476,470

 

 

 

555,192

 

Total liabilities and stockholders’ equity

 

$

510,384

 

 

$

594,968

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

1


 

Atea Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(in thousands, except share and per share amounts)

(Unaudited)

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

2


 

 

Atea Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Equity

(in thousands, except share amounts)

(Unaudited)

 

 

Common Stock

 

 

Additional

 

 

Accumulated Other

 

 

Accumulated

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

Paid-in Capital

 

 

Comprehensive Gain (Loss)

 

 

Deficit

 

 

Stockholders' Equity

 

Balance—January 1, 2024

 

 

83,435,513

 

 

$

83

 

 

$

750,737

 

 

$

207

 

 

$

(195,835

)

 

$

555,192

 

Issuance upon vesting of restricted stock units

 

 

729,032

 

 

 

1

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

Issuance of common stock under employee stock purchase plan

 

 

58,555

 

 

 

 

 

 

150

 

 

 

 

 

 

 

 

 

150

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

12,586

 

 

 

 

 

 

 

 

 

12,586

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

(388

)

 

 

 

 

 

(388

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(63,169

)

 

 

(63,169

)

Balance—March 31, 2024

 

 

84,223,100

 

 

 

84

 

 

 

763,472

 

 

 

(181

)

 

 

(259,004

)

 

 

504,371

 

Issuance upon vesting of restricted stock units

 

 

198,900

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

12,720

 

 

 

 

 

 

 

 

 

12,720

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

(99

)

 

 

 

 

 

(99

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(40,522

)

 

 

(40,522

)

Balance—June 30, 2024

 

 

84,422,000

 

 

$

84

 

 

$

776,192

 

 

$

(280

)

 

$

(299,526

)

 

$

476,470

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Additional

 

 

Accumulated Other

 

 

Accumulated

 

 

Total

 

 

 

Shares

 

 

Amount

 

 

Paid-in Capital

 

 

Comprehensive Gain (Loss)

 

 

Deficit

 

 

Stockholders' Equity

 

Balance—January 1, 2023

 

 

83,287,639

 

 

$

83

 

 

$

701,052

 

 

$

(684

)

 

$

(59,879

)

 

$

640,572

 

Issuance upon vesting of restricted stock units

 

 

53,935

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock under employee stock purchase plan

 

 

57,803

 

 

 

 

 

 

165

 

 

 

 

 

 

 

 

 

165

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

12,535

 

 

 

 

 

 

 

 

 

12,535

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

377

 

 

 

 

 

 

377

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,467

)

 

 

(35,467

)

Balance—March 31, 2023

 

 

83,399,377

 

 

 

83

 

 

 

713,752

 

 

 

(307

)

 

 

(95,346

)

 

 

618,182

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

12,353

 

 

 

 

 

 

 

 

 

12,353

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(28,183

)

 

 

(28,183

)

Balance—June 30, 2023

 

 

83,399,377

 

 

$

83

 

 

$

726,105

 

 

$

(310

)

 

$

(123,529

)

 

$

602,349

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

3


 

Atea Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(in thousands)

(Unaudited)

 

 

Six Months Ended
June 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(103,691

)

 

$

(63,650

)

Adjustments to reconcile net loss to net cash used in
   operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

25,306

 

 

 

24,888

 

Depreciation and amortization expense

 

 

208

 

 

 

208

 

Accretion of premium and discounts on marketable securities

 

 

(6,512

)

 

 

(6,784

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

8,194

 

 

 

1,449

 

Other assets

 

 

 

 

 

98

 

Accounts payable

 

 

1,218

 

 

 

1,411

 

Accrued expenses and other liabilities

 

 

(6,703

)

 

 

(3,510

)

Operating lease liabilities

 

 

(87

)

 

 

(80

)

Net cash used in operating activities

 

 

(82,067

)

 

 

(45,970

)

Cash flows from investing activities

 

 

 

 

 

 

Purchases of marketable securities

 

 

(174,460

)

 

 

(309,844

)

Sales and maturities of marketable securities

 

 

355,948

 

 

 

380,889

 

Net cash provided by investing activities

 

 

181,488

 

 

 

71,045

 

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from issuance of common stock under ESPP

 

 

150

 

 

 

165

 

Net cash provided by financing activities

 

 

150

 

 

 

165

 

Net increase in cash, cash equivalents and restricted cash

 

 

99,571

 

 

 

25,240

 

Cash, cash equivalents and restricted cash at the beginning of period

 

 

143,823

 

 

 

188,658

 

Cash, cash equivalents and restricted cash at the end of period

 

$

243,394

 

 

$

213,898

 

Cash, cash equivalents and restricted cash at the end of period:

 

 

 

 

 

 

Cash and cash equivalents

 

$

243,394

 

 

$

213,700

 

Restricted cash

 

 

 

 

 

198

 

Total cash, cash equivalents and restricted cash

 

$

243,394

 

 

$

213,898

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

4


 

 

 

Atea Pharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

(in thousands, except share and per share amounts)

(Unaudited)

1. Organization

Business Overview

Atea Pharmaceuticals, Inc., together with its wholly owned subsidiary, Atea Pharmaceuticals Securities Corporation, is referred to herein on a consolidated basis as “Atea” or the “Company”.

The Company is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from serious viral infections. Currently, Atea is in the process of completing SUNRISE-3, a global Phase 3 clinical trial evaluating bemnifosbuvir for the treatment of Coronavirus disease 2019 (“COVID-19”). All patients in the SUNRISE-3 clinical trial, which is fully enrolled with 2,295 patients, have completed their last scheduled study visit. Atea is preparing for the analysis of the clinical trial data and subsequent reporting of the trial results. Atea is also currently conducting a global Phase 2 clinical trial evaluating the combination of bemnifosbuvir and ruzasvir for the treatment of hepatitis C virus (“HCV”), which is fully enrolled with 275 patients.

Liquidity and Capital Resources

As of June 30, 2024, the Company had $502.2 million in cash, cash equivalents and marketable securities, which the Company believes will be sufficient to fund its operations for a period through at least twelve months from the issuance date of these condensed consolidated financial statements.

In November 2021, the Company entered into an open market sales agreement (“Sales Agreement”) with Jefferies LLC (“Jefferies”), under which the Company may from time to time offer and sell shares of its common stock for an aggregate offering price of up to $200.0 million, through or to Jefferies, acting as sales agent or principal. The shares will be offered and sold under the Company’s shelf registration statement on Form S-3 and a related prospectus filed with the Securities and Exchange Commission (“SEC”) on November 24, 2021, as amended. The Company has agreed to pay Jefferies a commission of 3.0% of the aggregate gross proceeds from each sale of shares, reimburse legal fees and disbursements and provide Jefferies with customary indemnification and contribution rights. As of June 30, 2024, no shares have been issued under the Sales Agreement.

Risks and Uncertainties

The Company is subject to risks and uncertainties common to clinical-stage biopharmaceutical companies. These risks include, but are not limited to, potential failure of preclinical and clinical studies, uncertainties associated with research and development activities generally, competition from technical innovations of others, dependence upon key personnel, compliance with governmental regulations, the need to obtain marketing approval for any product candidate that the Company may develop, the need to gain broad acceptance among patients, payers and health care providers to successfully commercialize any product for which marketing approval is obtained and the need to secure and maintain adequate intellectual property protection for the Company’s proprietary technology and products. Further, the Company is currently dependent on third-party service providers for much of its preclinical research, clinical development and manufacturing activities. Product candidates currently under development, including most notably the combination of bemnifosbuvir and ruzasvir for the treatment of HCV, will require significant amounts of additional capital and additional research and development efforts, and all the Company’s product candidates will require regulatory approval, prior to commercialization. Even if the Company is able to generate revenues from the sale of its product candidates, if approved, it may not become profitable. If the Company fails to become profitable or is unable to sustain profitability on a continuing basis, then it may be unable to continue its operations at planned levels and be forced to reduce its operations.

The Company may seek additional capital through one or more of a combination of financing through the sale of additional equity securities, debt financing, or funding in connection with any new collaborative relationships it may enter into or other arrangements. There can be no assurance that the Company will be able to obtain such additional funding, on terms acceptable to the Company, on a timely basis or at all. The terms of any financing may adversely affect the holdings or the rights of the Company’s existing stockholders. Geopolitical events,

5


 

including civil or political unrest and terrorism, have resulted in a significant disruption of global business and financial markets. In addition, recent or future market volatility, increased inflation and higher interest rates, if sustained, may increase the Company’s cost of financing and may restrict our access to potential sources of future liquidity.

2. Summary of Significant Accounting Policies

Basis of Presentation

The unaudited interim condensed consolidated financial statements of the Company included herein have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) as found in the Accounting Standards Codification (“ASC”), Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”) and the rules and regulations of the SEC. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted from this report, as is permitted by such SEC rules and regulations. Accordingly, these unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and the notes thereto for the year ended December 31, 2023 included in the Company’s Annual Report on Form 10-K filed with the SEC on February 28, 2024.

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of June 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2024 and 2023, the condensed consolidated statements of stockholders’ equity for the three and six months ended June 30, 2024 and 2023, and the condensed consolidated statements of cash flows for the six months ended June 30, 2024 and 2023 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of June 30, 2024, the results of its operations for the three and six months ended June 30, 2024 and 2023 and its cash flows for the six months ended June 30, 2024 and 2023. The results for the three months ended June 30, 2024 are not necessarily indicative of results to be expected for the year ending December 31, 2024, or any other interim period.

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and in these accompanying notes. The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors and assumptions that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates, which include but are not limited to estimates of accrued research and development expenses, valuation of marketable securities, the valuation of stock-based awards, valuation of operating lease right-of-use assets and lease liabilities and income taxes. Changes in estimates are recorded in the period in which such changes become known.

Principles of Consolidation

The condensed consolidated financial statements include the accounts of Atea Pharmaceuticals, Inc. and its wholly-owned subsidiary, Atea Pharmaceuticals Securities Corporation. All intercompany amounts have been eliminated in consolidation.

Significant Accounting Policies

There were no changes in the Company’s significant accounting policies as described in the Annual Report on Form 10-K for the year ended December 31, 2023 filed with the SEC on February 28, 2024.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies that the Company adopts as of the specified effective date. The Company does not believe that the adoption of recently issued standards have or may have a material impact on its condensed consolidated financial statements and disclosures.

6


 

3. Collaboration Agreement

In October 2020, the Company entered into a License Agreement (“Roche License Agreement”) with F. Hoffmann-LaRoche Ltd. and Genentech, Inc. (together, “Roche”) under which the Company granted an exclusive license for certain development and commercialization rights related to bemnifosbuvir outside of the United States (other than for certain HCV uses) to Roche.

In November 2021, Roche provided the Company with a notice of termination of the Roche License Agreement which became effective in February 2022. Upon termination, the rights and licenses granted by the Company to Roche under the Roche License Agreement were returned to the Company, resulting in the Company having all rights to continue the clinical development and future commercialization of bemnifosbuvir worldwide. Global development plan activities and related cost sharing between the parties continued through the effective date of the termination.

The activities to complete the global development plan were accounted for under ASC 808. Expenses incurred and reimbursements made or received from Roche were accounted for pursuant to ASC 730, Research and Development. As such, the Company was expensing costs as incurred, including any reimbursements made to Roche, and recognizing reimbursement received from Roche as a reduction of research and development expense through the effective date of the termination.

For the three months ended June 30, 2024 and 2023, the Company recorded net credits of $0 and $7,877, respectively, from Roche. For the six months ended June 30, 2024 and 2023, the Company recorded net credits of $1,292 and $8,877, respectively, from Roche. The credits recorded represent changes in estimate as a result of close out activities and related reporting of amounts incurred by Roche associated with the global development plan. The close out activities were completed by Roche as of March 31, 2024. As a result, the Company did not record any net credits in the three months ended June 30, 2024 and does not expect to receive any related amounts from Roche in the future.

4. Marketable Securities

 

 

 

 

 

 

 

 

 

 

 

As of June 30, 2024

 

 

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

Marketable Securities

 

 

 

 

 

 

 

 

 

 

 

 

US Treasury obligations

 

$

148,097

 

 

$

1

 

 

$

(157

)

 

$

147,941

 

US Government agency securities

 

 

18,139

 

 

 

 

 

 

(19

)

 

 

18,120

 

Commercial paper

 

 

13,842

 

 

 

 

 

 

(20

)

 

 

13,822

 

Corporate bonds

 

 

79,022

 

 

 

3

 

 

 

(88

)

 

 

78,937

 

Total

 

$

259,100

 

 

$

4

 

 

$

(284

)

 

$

258,820

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2023

 

 

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Fair Value

 

Marketable Securities

 

 

 

 

 

 

 

 

 

 

 

 

US Treasury obligations

 

$

155,816

 

 

$

145

 

 

$

(23

)

 

$

155,938

 

US Government agency securities

 

 

178,115

 

 

 

96

 

 

 

(51

)

 

 

178,160

 

Commercial paper

 

 

39,461

 

 

 

14

 

 

 

(27

)

 

 

39,448

 

Corporate bonds

 

 

60,684

 

 

 

65

 

 

 

(12

)

 

 

60,737

 

Total

 

$

434,076

 

 

$

320

 

 

$

(113

)

 

$

434,283

 

As of June 30, 2024, the Company held 56 securities that were in an unrealized loss position of $284 with an aggregate fair value of $235,848. The Company has the intent and ability to hold such securities until recovery. As a result, the Company did not record any charges for credit-related impairments for its marketable debt securities for either the three or the six months ended June 30, 2024.

None of the securities had remaining maturities longer than one year as of June 30, 2024.

7


 

The Company received proceeds of $355,948 and $380,889 from sales and maturities of marketable securities during the six months ended June 30, 2024 and 2023, respectively.

5. Fair Value Measurements

The following tables present information about the Company’s financial assets measured at fair value on a recurring basis and indicate the level of the fair value hierarchy utilized to determine such fair values:

 

 

Fair Value Measurements as of
June 30, 2024

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

235,894

 

 

$

 

 

$

 

 

$

235,894

 

Marketable Securities

 

 

 

 

 

 

 

 

 

 

 

 

US Treasury obligations

 

 

 

 

 

147,941

 

 

 

 

 

 

147,941

 

US Government agency securities

 

 

 

 

 

18,120

 

 

 

 

 

 

18,120

 

Commercial paper

 

 

 

 

 

13,822

 

 

 

 

 

 

13,822

 

Corporate bonds

 

 

 

 

 

78,937

 

 

 

 

 

 

78,937

 

Total

 

$

235,894

 

 

$

258,820

 

 

$

 

 

$

494,714

 

 

 

 

Fair Value Measurements as of
December 31, 2023

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

143,740

 

 

$

 

 

$

 

 

$

143,740

 

Marketable Securities

 

 

 

 

 

 

 

 

 

 

 

 

US Treasury obligations

 

 

 

 

 

155,938

 

 

 

 

 

 

155,938

 

US Government agency securities

 

 

 

 

 

178,160

 

 

 

 

 

 

178,160

 

Commercial paper

 

 

 

 

 

39,448

 

 

 

 

 

 

39,448

 

Corporate bonds

 

 

 

 

 

60,737

 

 

 

 

 

 

60,737

 

Total

 

$

143,740

 

 

$

434,283

 

 

$

 

 

$

578,023

 

The Company’s assets with fair value categorized as Level 1 within the fair value hierarchy include money market funds. Money market funds are publicly traded mutual funds and are presented as cash equivalents on the unaudited condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023.

The Company’s assets with fair value categorized as Level 2 within the fair value hierarchy include treasury obligations, government agency securities, commercial paper and corporate bonds with fair values determined by utilizing information from third party pricing sources for identical or similar assets and liabilities in active market.

There were no transfers between Level 1, Level 2 or Level 3 categories during the six months ended June 30, 2024.

6. Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consist of the following:

 

 

June 30,
2024

 

 

December 31,
2023

 

Research and development, including manufacturing and clinical expenditures

 

$

15,299

 

 

$

20,999

 

Payroll and payroll related

 

 

4,188

 

 

 

5,696

 

Professional fees and other

 

 

882

 

 

 

669

 

Total accrued expenses and other current liabilities

 

$

20,369

 

 

$

27,364

 

 

7. Common Stock

At June 30, 2024, the authorized capital of the Company included 300,000,000 shares of the Company’s common stock, of which 84,422,000 shares of the Company’s common stock were issued and outstanding. On all matters to be voted upon by the holders of the Company’s common stock, holders of the Company’s common stock are

8


 

entitled to one vote per share. The holders of the Company’s common stock have no preemptive, redemption or conversion rights.

8. Stock-based Compensation

In October 2020, the Company’s shareholders approved the Company’s 2020 Incentive Award Plan (“2020 Plan”). The 2020 Plan initially provided for the issuance of up to 7,924,000 shares of the Company's common stock and for the grant of incentive stock options or other incentive awards to employees, officers, directors and consultants of the Company. The number of shares of the Company's common stock that may be issued under the 2020 Plan is also subject to increase on the first day of each calendar year equal to the lesser of i) 5% of the aggregate number of shares of the Company's common stock outstanding on the final day of the immediately preceding calendar year or ii) such smaller number of shares as is determined by the board of directors. Through December 31, 2023, the shares available under the plan had increased by 12,450,364 shares since the inception of the 2020 Plan. In January 2024, the shares of the Company’s common stock available under the 2020 Plan increased by 4,171,775 shares. As of June 30, 2024, 5,370,429 shares of the Company’s common stock were available for future issuance under the 2020 Plan.

The 2020 Plan replaced and is the successor of the Company’s 2013 Equity Incentive Plan, as amended (“2013 Plan”). Upon any cancellation of outstanding option awards to purchase shares of the Company's common stock under the 2013 Plan, such shares will be made available for grant under the 2020 Plan.

Restricted Stock Units

During the three and six months ended June 30, 2024, the Company granted 177,600 and 1,126,100 restricted stock units to employees and directors under the 2020 Plan with an aggregate grant date fair market value of $611 and $4,557, respectively.

The restricted stock unit awards vest in three annual installments. Below is the activity related to restricted stock units for the six months ended June 30, 2024.

 

 

Number of
Shares

 

 

Weighted Average
Grant Date Fair Value

 

Outstanding at January 1, 2024

 

 

2,337,517

 

 

$

4.69

 

Granted

 

 

1,126,100

 

 

$

4.05

 

Released

 

 

(927,932

)

 

$

4.65

 

Cancelled

 

 

(12,633

)

 

$

4.62

 

Unvested shares at June 30, 2024

 

 

2,523,052

 

 

$

4.42

 

As of June 30, 2024, total unrecognized compensation expense related to restricted stock units was $9,158, which amount is being recognized over a remaining weighted average period of 1.9 years.

Performance-based Restricted Stock Units

As of December 31, 2023 the Company had 724,970 performance-based restricted stock units (“2022 PSUs”) outstanding. The 2022 PSUs provide for a performance period from February 1, 2022 through January 31, 2025 to achieve up to six defined performance metrics. The percentage of 2022 PSUs eligible to vest will be determined based on the number of metrics achieved during the performance period and may range from 0% to 200%. The Company has not recognized any compensation expense through June 30, 2024, as achievement of the minimum performance criteria had not been deemed probable. The vesting of any eligible 2022 PSUs will occur in equal installments on January 31, 2025 and January 31, 2026.

During the six months ended June 30, 2024, the Company granted 1,057,900 performance-based restricted stock units (“2024 PSUs”) to employees with an aggregate grant date fair value of $4,401. The 2024 PSUs provide for a performance period from February 1, 2024 through January 31, 2027 to achieve up to four defined metrics. The percentage of 2024 PSUs eligible to vest will be determined based on the number of metrics achieved during the performance period and may range from 0% to 200%. As of June 30, 2024 one metric was deemed probable of achievement resulting in expense recognition of 50% of the grant date value of the 2024 PSUs. Compensation expense is being recognized from the grant date through the final vest date of January 31, 2027. The Company recorded compensation expense of $183 and $303 for the three and six months ended June 30, 2024.

9


 

The following table summarizes the activity related to performance-based restricted stock units for the six months ended June 30, 2024.

 

 

Number of
Shares

 

 

Weighted Average
Grant Date Fair Value

 

Outstanding at January 1, 2024

 

 

724,970

 

 

$

7.14

 

Granted

 

 

1,057,900

 

 

$

4.16

 

Released

 

 

 

 

$

 

Cancelled

 

 

 

 

$

 

Unvested shares at June 30, 2024

 

 

1,782,870

 

 

$

5.37

 

Stock Options

The following table summarizes stock option activity for the six months ended June 30, 2024.

 

 

Number of
Shares

 

 

Weighted
Average
Exercise Price
Per Share

 

 

Weighted
Average
Remaining
Contractual
Term (years)

 

 

Aggregate
Intrinsic
Value
($000s)

 

Outstanding at January 1, 2024

 

 

17,017,319

 

 

$

15.30

 

 

 

7.1

 

 

$

5,080

 

Granted

 

 

3,179,550

 

 

$

4.10

 

 

 

 

 

 

 

Exercised

 

 

 

 

$

 

 

 

 

 

 

 

Cancelled

 

 

(38,867

)

 

$

13.10

 

 

 

 

 

 

 

Outstanding at June 30, 2024

 

 

20,158,002

 

 

$

13.54

 

 

 

7.1

 

 

$

5,958

 

Vested and expected to vest at June 30, 2024

 

 

20,158,002

 

 

$

13.54

 

 

 

7.1

 

 

$

5,958

 

Vested and exercisable at June 30, 2024

 

 

13,094,578

 

 

$

16.33

 

 

 

6.2

 

 

$

5,937

 

During the three and six months ended June 30, 2024 the Company granted 247,200 and 3,179,550 stock options with an aggregate grant date fair value of $555 and $9,539, respectively.

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the estimated fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock.

Stock options generally vest over a service period of four years after grant and have a contractual term of ten years. As of June 30, 2024, total unrecognized compensation expense related to stock option awards was $42,058, which amount is being recognized over a remaining weighted average period of 2.4 years.

Employee Stock Purchase Plan

In October 2020, the Company’s shareholders approved the Employee Stock Purchase Plan (“ESPP”), which became effective upon the closing of the Company’s initial public offering (“IPO”) in November 2020. The Company initially reserved a total of 1,187,000 shares of the Company’s common stock for issuance under the ESPP. The ESPP provides that the number of shares reserved and available for issuance under the ESPP will be increased on January 1 of each calendar year by 1% of the number of shares of the Company’s common stock issued and outstanding on the immediately preceding December 31 or such lesser amount as specified by the board of directors. Through December 31, 2022, there was no increase in the number of shares reserved for issuance under the ESPP. In January 2023 and January 2024, the number of shares of the Company’s common stock available for issuance under the ESPP was increased by 832,876 shares and 834,355 shares, respectively. As of June 30, 2024, 2,672,701 shares of the Company’s common stock were available for issuance under the ESPP.

Under the ESPP, the Company issued 58,555 shares of the Company's common stock for proceeds of $150 during the six months ended June 30, 2024.

10


 

Stock-based Compensation Expense

Stock-based compensation expense by award type included within the unaudited condensed consolidated statements of operations and comprehensive loss was as follows:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Stock options

 

$

11,131

 

 

$

11,417

 

 

$

22,272

 

 

$

23,297

 

Restricted stock units

 

 

1,372

 

 

 

903

 

 

 

2,662

 

 

 

1,503

 

Performance-based stock units

 

 

183

 

 

 

 

 

 

303

 

 

 

 

Employee stock purchase plan

 

 

34

 

 

 

33

 

 

 

69

 

 

 

88

 

Total stock-based compensation expense

 

$

12,720

 

 

$

12,353

 

 

$

25,306

 

 

$

24,888

 

Stock-based compensation expense is classified as follows:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Research and development expense

 

$

6,073

 

 

$

5,545

 

 

$

12,054

 

 

$

11,473

 

General and administrative

 

 

6,647

 

 

 

6,808

 

 

 

13,252

 

 

 

13,415

 

Total stock-based compensation expense

 

$

12,720

 

 

$

12,353

 

 

$

25,306

 

 

$

24,888

 

 

9. Net Loss Per Share

Basic and diluted earnings per share are calculated as follows:

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

 

 

 

 

 

 

2024

 

 

2023

 

Net loss

 

$

(40,522

)

 

$

(28,183

)

 

$

(103,691

)

 

$

(63,650

)

Weighted average common shares outstanding, basic and diluted

 

 

84,253,700

 

 

 

83,399,377

 

 

 

84,069,646

 

 

 

83,361,398