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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, 2021

 

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 001-34655

 

AVEO PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

04-3581650

(State or Other Jurisdiction of

Incorporation or Organization)

(I.R.S. Employer

Identification No.)

 

30 Winter Street, Boston, Massachusetts 02108

(Address of principal executive offices) (Zip Code)

(857400-0101

(Registrant’s telephone number, including area code)

 

 

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

AVEO

Nasdaq Capital 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, smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting 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  

Number of shares of the registrant’s Common Stock, $0.001 par value, outstanding on July 30, 2021: 34,373,995

 

 

 


 

 

AVEO PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE QUARTER ENDED JUNE 30, 2021

TABLE OF CONTENTS

 

 

 

 

Page

No.

 

 

 

 

PART I. FINANCIAL INFORMATION

 

 

 

 

 

Item 1.

 

Financial Statements

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of June 30, 2021 and December 31, 2020

6

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2021 and 2020

7

 

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Six Months Ended June 30, 2021 and 2020

8

 

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2021 and 2020

9

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020

11

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements

12

 

 

 

 

Item 2.

 

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

36

 

 

 

 

Item 4.

 

Controls and Procedures

48

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

Item 1A.

 

Risk Factors

49

 

 

 

 

Item 6.

 

Exhibits

82

 

 

 

 

 

 

Signatures

83

 


2


 

 

Cautionary Note Regarding Forward-Looking Statements and Industry Data

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. All statements other than statements of historical fact contained in this report are statements that could be deemed forward-looking statements, including, without limitation, statements with respect to the plans, strategies and objectives of management for future operations; statements concerning product research, development and commercialization plans, timelines and anticipated results; statements of expectation or belief; statements with respect to clinical trials and studies; statements with respect to the therapeutic potential of product candidates; any expectations of revenue, expenses, earnings or losses from operations, or other financial results; and statements of assumptions underlying any of the foregoing. Without limiting the foregoing, the words “anticipates”, “believes”, “could”, “estimates”, “expects”, “intends”, “may”, “plans”, “seeks”, “will”, “strategy”, “potential”, “should”, “would” and other similar language, whether in the negative or affirmative, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements may include, but are not limited to, statements about:

 

our plans surrounding the launch and commercialization of FOTIVDA;

 

our plans to develop our clinical stage assets and commercialize our product candidates;

 

our manufacturing, marketing and sales capabilities and strategy;

 

the rate and degree of market acceptance and clinical utility of our products;

 

the initiation, timing, progress and results of future clinical trials, and our development programs;

 

our ability to secure new collaborations, maintain existing collaborations or obtain additional funding;

 

our intellectual property position;

 

the potential of ficlatuzumab, AV-380 or other product candidates that we in-license, or may elect to in-license, or may acquire in the future;

 

the timing or likelihood of regulatory filings and approvals;

 

the implementation of our business model, strategic plans for our business, product candidates and technology;

 

our competitive position;

 

developments and projections relating to our competitors and our industry;

 

impacts resulting from the COVID-19 pandemic and responsive actions relating thereto;

 

our estimates of the period in which we anticipate that existing cash, cash equivalents and investments will enable us to fund our current and planned operations; and

 

our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

Our actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors. We therefore caution you against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in these forward-looking statements include the factors discussed below under the heading “Risk Factor Summary,” and the risk factors detailed further in Item 1A., “Risk Factors” of Part I of this report and in our U.S. Securities and Exchange Commission reports filed after this report.

This report also includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties as well as our own estimates. All of the market data used in this report involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Our estimates of the potential market opportunities for our product candidates include several key assumptions based on our industry knowledge, industry publications, third-party research and other surveys, which may be based on a small sample size and may fail to accurately reflect market opportunities. While we believe that our internal assumptions are reasonable, no independent source has verified such assumptions.

The forward-looking statements included in this quarterly report represent our estimates as of the filing date of this quarterly report. We specifically disclaim any obligation to update these forward-looking statements in the future. These forward-looking

3


 

statements should not be relied upon as representing our estimates or views as of any date subsequent to the date of this quarterly report.

Risk Factor Summary

Investment in our securities involves risk. You should carefully consider the following summary of what we believe to be the principle risks facing our business, in addition to the risks described more fully in Item 1A., “Risk Factors” of Part I of this Quarterly Report on Form 10-Q and other information included in this report. The risks and uncertainties described below are not the only risks and uncertainties we face. Additional risks and uncertainties not presently known to us or that we presently deem less significant may also impair our business operations.

If any of the following risks occur, our business, financial condition and results of operations and future growth prospects could be materially and adversely affected, and the actual outcomes of matters as to which forward-looking statements are made in this report could be materially different from those anticipated in such forward-looking statements.

 

We have incurred significant operating losses, anticipate that we will continue to incur significant operating expenses for the foreseeable future and may never generate significant revenue or achieve or sustain profitability.

 

We may require substantial additional funding to advance our pipeline of clinical stage assets, and if we are unable to obtain this necessary capital when needed, we could be forced to delay, limit, reduce or terminate our research, product development or commercialization efforts.

 

We have only recently transitioned from a development stage biopharmaceutical company to a commercial stage biopharmaceutical company, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

 

We depend heavily on the success of our product, FOTIVDA, and on our clinical stage assets, including tivozanib (in other indications), ficlatuzumab and AV-380. If we are unable to complete the clinical development of, obtain marketing approval for or successfully commercialize our product candidates, our business will be materially harmed.

 

The COVID-19 pandemic has adversely disrupted our ability to commercialize FOTIVDA, to manufacture clinical and commercial product and to initiate new trials or complete ongoing clinical trials and may have other adverse effects on our business and operations.

 

If we or our collaborators experience delays or difficulties in the enrollment of patients in clinical trials, receipt of necessary regulatory approvals could be delayed or prevented.

 

If clinical trials of any product candidates that we, or any collaborators, may develop fail to satisfactorily demonstrate safety and efficacy to the FDA and other regulators, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of these product candidates.

 

We face substantial competition from existing approved products and our competitors may also discover, develop or commercialize new competing products before, or more successfully, than we do.

 

Adverse events or undesirable side effects caused by, or other unexpected properties of, product candidates that we develop may be identified during development and could delay or prevent their marketing approval or limit their use.

 

We rely in part on third parties to produce our preclinical and clinical product candidate supplies and to conduct clinical trials of our internally-developed product candidates, and those third parties may not perform satisfactorily, including by failing to deliver supplies on time or to meet deadlines for the completion of such trials, research or testing.

 

We rely on our licensee EUSA, over whom we have little control, for the sales, marketing and distribution efforts associated with the commercialization of FOTIVDA in certain European countries and any failure by EUSA to devote the necessary resources and attention to market and sell FOTIVDA effectively and successfully may materially impact our ability to generate revenue.

 

Any failure by a third-party manufacturer or a third-party supplier to timely produce or provide required manufacturing supplies for us or to safely store product candidate supplies and commercial supplies of FOTIVDA may delay or impair our ability to manufacture product, initiate or complete our clinical trials or commercialize our product candidates.

 

We may not be successful in establishing or maintaining strategic partnerships to further the development of our therapeutic programs. Additionally, if any of our current or future strategic partners fails to perform its obligations or terminates the partnership, the development and commercialization of the product candidates under such agreement could

4


 

 

be delayed or terminated and, such failures or terminations could have a material adverse effect on our operations and business.

 

We could be unsuccessful in obtaining or maintaining adequate patent protection for one or more of our product candidates, or the scope of our patent protection could be insufficiently broad, which could result in competition and a decrease in the potential market share for our product candidates.

5


 

AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except par value amounts)

(Unaudited)

 

 

 

June 30,

2021

 

 

December 31,

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

74,735

 

 

$

61,761

 

Marketable securities

 

 

28,185

 

 

 

 

Trade receivables, net

 

 

4,220

 

 

 

 

Partnership receivables

 

 

1,365

 

 

 

1,197

 

Clinical trial retainers

 

 

482

 

 

 

355

 

Other prepaid expenses and other current assets

 

 

2,753

 

 

 

2,195

 

Total current assets

 

 

111,740

 

 

 

65,508

 

Property and equipment, net

 

 

310

 

 

 

343

 

Operating lease right-of-use asset

 

 

676

 

 

 

903

 

Other assets

 

 

258

 

 

 

158

 

Total assets

 

$

112,984

 

 

$

66,912

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

3,162

 

 

$

3,380

 

Accrued clinical trial costs and contract research

 

 

4,819

 

 

 

4,550

 

Other accrued liabilities

 

 

6,779

 

 

 

4,463

 

Operating lease liability

 

 

324

 

 

 

369

 

Loans payable, net of discount

 

 

 

 

 

1,056

 

Deferred revenue

 

 

1,565

 

 

 

1,974

 

Deferred research and development reimbursements

 

 

36

 

 

 

164

 

PIPE Warrant liability (Note 7)

 

 

 

 

 

199

 

Other liabilities (Note 6)

 

 

790

 

 

 

790

 

Total current liabilities

 

 

17,475

 

 

 

16,945

 

Loans payable, net of current portion and discount

 

 

32,725

 

 

 

12,716

 

Deferred revenue, non-current

 

 

 

 

 

578

 

Operating lease liability, non-current

 

 

149

 

 

 

336

 

Other liabilities, non-current (Note 6)

 

 

2,432

 

 

 

1,043

 

Total liabilities

 

 

52,781

 

 

 

31,618

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Preferred stock, $.001 par value: 5,000 shares authorized at June 30,

   2021 and December 31, 2020; no shares issued and outstanding at each of

   June 30, 2021 and December 31, 2020

 

 

 

 

 

 

Common stock, $.001 par value: 50,000 shares authorized at June 30,

   2021 and December 31, 2020; 34,374 shares issued and outstanding at

   June 30, 2021 and 26,883 issued and outstanding at December 31, 2020

 

 

34

 

 

 

27

 

Additional paid-in capital

 

 

717,093

 

 

 

656,472

 

Accumulated deficit

 

 

(656,924

)

 

 

(621,205

)

Total stockholders’ equity

 

 

60,203

 

 

 

35,294

 

Total liabilities and stockholders’ equity

 

$

112,984

 

 

$

66,912

 

 

See accompanying notes.

 

6


 

 

AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FOTIVDA U.S. product revenue, net

 

$

6,735

 

 

$

-

 

 

$

7,801

 

 

$

-

 

Partnership licensing and royalty revenue

 

 

821

 

 

 

749

 

 

 

1,675

 

 

 

1,533

 

 

 

 

7,556

 

 

 

749

 

 

 

9,476

 

 

 

1,533

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of products sold

 

 

822

 

 

 

-

 

 

 

960

 

 

 

-

 

Research and development

 

 

6,878

 

 

 

4,419

 

 

 

12,675

 

 

 

12,245

 

Selling, general and administrative

 

 

14,920

 

 

 

3,737

 

 

 

30,020

 

 

 

7,409

 

 

 

 

22,620

 

 

 

8,156

 

 

 

43,655

 

 

 

19,654

 

Loss from operations

 

 

(15,064

)

 

 

(7,407

)

 

 

(34,179

)

 

 

(18,121

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(1,128

)

 

 

(349

)

 

 

(1,739

)

 

 

(664

)

Change in fair value of PIPE Warrant liability

 

 

2,595

 

 

 

450

 

 

 

199

 

 

 

3,098

 

Other income (expense), net

 

 

1,467

 

 

 

101

 

 

 

(1,540

)

 

 

2,434

 

Net loss

 

$

(13,597

)

 

$

(7,306

)

 

$

(35,719

)

 

$

(15,687

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

 

$

(0.40

)

 

$

(0.42

)

 

$

(1.16

)

 

$

(0.94

)

Weighted average number of common shares outstanding

 

 

34,362

 

 

 

17,364

 

 

 

30,915

 

 

 

16,722

 

See accompanying notes.

7


 

AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(In thousands)

(Unaudited)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Net loss

 

$

(13,597

)

 

$

(7,306

)

 

$

(35,719

)

 

$

(15,687

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on available-for-sale securities

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

Comprehensive loss

 

$

(13,597

)

 

$

(7,307

)

 

$

(35,719

)

 

$

(15,688

)

 

See accompanying notes.

 

8


 

 

AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands)

(Unaudited)

 

 

 

Common Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Par Value

 

 

Additional

Paid-in

Capital

 

 

Accumulated

Other

Comprehensive

Income

 

 

Accumulated

Deficit

 

 

Total

Stockholders'

Equity

 

Balance at December 31, 2020

 

 

26,883

 

 

$

27

 

 

$

656,472

 

 

$

 

 

$

(621,205

)

 

$

35,294

 

Issuance of common stock in a public

   offering

   (net of issuance costs of $3.5 million)

 

 

6,900

 

 

 

7

 

 

 

51,711

 

 

 

 

 

 

 

 

 

51,718

 

Issuance of common stock from the

   SVB Leerink sales agreement (net

   of issuance costs of $0.1 million)

 

 

331

 

 

 

 

 

 

3,377

 

 

 

 

 

 

 

 

 

3,377

 

Issuance of common stock in

   connection with warrant exercises

 

 

247

 

 

 

 

 

 

3,092

 

 

 

 

 

 

 

 

 

3,092

 

Stock-based compensation expense

   related to equity- classified awards

 

 

 

 

 

 

 

 

1,204

 

 

 

 

 

 

 

 

 

1,204

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,122

)

 

 

(22,122

)

Balance at March 31, 2021

 

 

34,361

 

 

$

34

 

 

$

715,856

 

 

$

 

 

$

(643,327

)

 

$

72,563

 

Stock-based compensation expense

   related to equity-classified awards

 

 

 

 

 

 

 

 

1,169

 

 

 

 

 

 

 

 

 

1,169

 

Issuance of common stock under

   employee stock purchase plan

 

 

13

 

 

 

 

 

 

68

 

 

 

 

 

 

 

 

 

68

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,597

)

 

 

(13,597

)

Balance at June 30, 2021

 

 

34,374

 

 

$

34

 

 

$

717,093

 

 

$

-

 

 

$

(656,924

)

 

$

60,203

 

 

9


 

 

AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Stockholders’ Equity

(In thousands)

(Unaudited)

 

 

 

Common Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Par Value

 

 

Additional

Paid-in

Capital

 

 

Accumulated

Other

Comprehensive

Income

 

 

Accumulated

Deficit

 

 

Total

Stockholders'

Equity

 

Balance at December 31, 2019

 

 

16,081

 

 

$

16

 

 

$

600,451

 

 

$

 

 

$

(585,621

)

 

$

14,846

 

Stock-based compensation expense

   related to equity- classified awards

 

 

 

 

 

 

 

 

543

 

 

 

 

 

 

 

 

 

543

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,381

)

 

 

(8,381

)

Balance at March 31, 2020

 

 

16,081

 

 

$

16

 

 

$

600,994

 

 

$

 

 

$

(594,002

)

 

$

7,008

 

Issuance of common stock in a public

   offering, excluding to related parties

   (net of issuance costs of $3.3 million)

 

 

5,221

 

 

 

5

 

 

 

24,106

 

 

 

 

 

 

 

 

 

24,111

 

Issuance of common stock in a public

   offering, to related parties

 

 

4,504

 

 

 

5

 

 

 

23,639

 

 

 

 

 

 

 

 

 

23,644

 

Stock-based compensation expense

   related to equity-classified awards

 

 

 

 

 

 

 

 

578

 

 

 

 

 

 

 

 

 

578

 

Issuance of common stock under

   employee stock purchase plan

 

 

2

 

 

 

 

 

 

18

 

 

 

 

 

 

 

 

 

18

 

Change in unrealized gain (loss) on

   investments

 

 

 

 

 

 

 

 

 

 

 

(1

)

 

 

 

 

 

(1

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,306

)

 

 

(7,306

)

Balance at June 30, 2020

 

 

25,808

 

 

$

26

 

 

$

649,335

 

 

$

(1

)

 

$

(601,308

)

 

$

48,052

 

 

10


 

 

AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

For the Six Months

Ended June 30,

 

 

 

2021

 

 

2020

 

Operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(35,719

)

 

$

(15,687

)

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

 

 

 

 

 

 

 

 

Depreciation and amortization

 

 

33

 

 

 

4

 

Stock-based compensation

 

 

2,373

 

 

 

1,121

 

Non-cash interest expense

 

 

428

 

 

 

200

 

Non-cash change in fair value of PIPE Warrant liability

 

 

(199

)

 

 

(3,098

)

Amortization of premium and discount on investments

 

 

10

 

 

 

(81

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Trade receivables, net

 

 

(4,220

)

 

 

 

Partnership receivables

 

 

(168

)

 

 

423

 

Prepaid expenses and other current assets

 

 

(685

)

 

 

(347

)

Operating lease right-of-use asset

 

 

227

 

 

 

(1,278

)

Other non-current assets

 

 

(100

)

 

 

 

Accounts payable

 

 

(219

)

 

 

319

 

Accrued contract research

 

 

269

 

 

 

(680

)

Other accrued liabilities

 

 

2,316