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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 September 30, 2020

 

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 November 6, 2020: 28,809,249

 

 

 


AVEO PHARMACEUTICALS, INC.

FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2020

TABLE OF CONTENTS

 

 

 

 

Page

No.

 

 

 

 

PART I. FINANCIAL INFORMATION

 

 

 

 

 

Item 1.

 

Financial Statements

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets as of September 30, 2020 and December 31, 2019

3

 

 

 

 

 

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2020 and 2019

4

 

 

 

 

 

 

Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Nine Months Ended September 30, 2020 and 2019

5

 

 

 

 

 

 

Condensed Consolidated Statements of Stockholders’ Equity for the Three Months Ended March 31, 2020 and 2019, June 30, 2020 and 2019 and September 30, 2020 and 2019

6

 

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2020 and 2019

8

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements

9

 

 

 

 

Item 2.

 

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

39

 

 

 

 

Item 4.

 

Controls and Procedures

58

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

Item 1.

 

Legal Proceedings

59

 

 

 

 

Item 1A.

 

Risk Factors

59

 

 

 

 

Item 6.

 

Exhibits

99

 

 

 

 

 

 

Signatures

100

 

2


AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except par value amounts)

(Unaudited)

 

 

 

September 30,

2020

 

 

December 31,

2019

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

39,848

 

 

$

29,785

 

Marketable securities

 

 

28,996

 

 

 

17,960

 

Accounts receivable

 

 

1,052

 

 

 

1,631

 

Clinical trial retainers

 

 

476

 

 

 

589

 

Other prepaid expenses and other current assets

 

 

1,270

 

 

 

635

 

Total current assets

 

 

71,642

 

 

 

50,600

 

Property and equipment, net

 

 

210

 

 

 

 

Operating lease right-of-use asset

 

 

1,012

 

 

 

 

Other assets

 

 

158

 

 

 

 

Total assets

 

$

73,022

 

 

$

50,600

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,999

 

 

$

1,466

 

Accrued clinical trial costs and contract research

 

 

5,925

 

 

 

5,680

 

Other accrued liabilities

 

 

3,411

 

 

 

2,336

 

Operating lease liability

 

 

436

 

 

 

 

Loans payable, net of discount

 

 

 

 

 

9,569

 

Deferred revenue

 

 

1,974

 

 

 

1,974

 

Deferred research and development reimbursements

 

 

240

 

 

 

93

 

PIPE Warrant liability (Note 7)

 

 

1,913

 

 

 

 

Other liabilities (Note 6)

 

 

790

 

 

 

 

Total current liabilities

 

 

16,688

 

 

 

21,118

 

Loans payable, net of current portion and discount

 

 

13,617

 

 

 

6,197

 

Deferred revenue

 

 

1,072

 

 

 

2,552

 

PIPE Warrant liability (Note 7)

 

 

 

 

 

5,097

 

Operating lease liability, non-current

 

 

379

 

 

 

 

Other liabilities (Note 6)

 

 

1,043

 

 

 

790

 

Total liabilities

 

 

32,799

 

 

 

35,754

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

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

   2020 and December 31, 2019; no shares issued and outstanding at each of

   September 30, 2020 and December 31, 2019

 

 

 

 

 

 

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

   2020 and December 31, 2019; 25,808 shares issued and outstanding at

   September 30, 2020 and 16,081 issued and outstanding at December 31, 2019

 

 

26

 

 

 

16

 

Additional paid-in capital

 

 

649,897

 

 

 

600,451

 

Accumulated other comprehensive income

 

 

1

 

 

 

 

Accumulated deficit

 

 

(609,701

)

 

 

(585,621

)

Total stockholders’ equity

 

 

40,223

 

 

 

14,846

 

Total liabilities and stockholders’ equity

 

$

73,022

 

 

$

50,600

 

 

See accompanying notes.

 

3


AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(In thousands, except per share amounts)

(Unaudited)

 

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Collaboration and licensing revenue

 

$

3,293

 

 

$

25,494

 

 

$

4,280

 

 

$

27,441

 

Partnership royalties

 

 

307

 

 

 

223

 

 

 

853

 

 

 

590

 

 

 

 

3,600

 

 

 

25,717

 

 

 

5,133

 

 

 

28,031

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

5,860

 

 

 

3,983

 

 

 

18,105

 

 

 

13,446

 

Selling, general and administrative

 

 

5,800

 

 

 

2,884

 

 

 

13,209

 

 

 

8,325

 

 

 

 

11,660

 

 

 

6,867

 

 

 

31,314

 

 

 

21,771

 

Income (loss) from operations

 

 

(8,060

)

 

 

18,850

 

 

 

(26,181

)

 

 

6,260

 

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense, net

 

 

(419

)

 

 

(467

)

 

 

(1,083

)

 

 

(1,482

)

Change in fair value of PIPE Warrant liability

 

 

86

 

 

 

(1,954

)

 

 

3,184

 

 

 

9,071

 

Other income (expense), net

 

 

(333

)

 

 

(2,421

)

 

 

2,101

 

 

 

7,589

 

Net income (loss)

 

$

(8,393

)

 

$

16,429

 

 

$

(24,080

)

 

$

13,849

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic net income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share

 

$

(0.33

)

 

$

1.02

 

 

$

(1.22

)

 

$

0.92

 

Weighted average number of common shares outstanding

 

 

25,808

 

 

 

16,074

 

 

 

19,773

 

 

 

15,079

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted net income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share

 

$

(0.33

)

 

$

1.02

 

 

$

(1.22

)

 

$

0.92

 

Weighted average number of common shares and dilutive

   common share equivalents outstanding

 

 

25,808

 

 

 

16,083

 

 

 

19,773

 

 

 

15,129

 

 

See accompanying notes.

4


AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Comprehensive Income (Loss)

(In thousands)

(Unaudited)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net income (loss)

 

$

(8,393

)

 

$

16,429

 

 

$

(24,080

)

 

$

13,849

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

2

 

 

 

(1

)

 

 

1

 

 

 

(1

)

Comprehensive income (loss)

 

$

(8,391

)

 

$

16,428

 

 

$

(24,079

)

 

$

13,848

 

 

See accompanying notes.

 

5


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

 

 

 

24,074

 

 

 

 

 

 

 

 

 

 

 

24,079

 

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

 

 

$

649,303

 

 

 

 

$

(1

)

 

$

(601,308

)

 

$

48,020

 

Stock-based compensation expense

   related to equity-classified awards

 

 

 

 

 

 

 

 

594

 

 

 

 

 

 

 

 

 

 

 

594

 

Change in unrealized gain (loss) on

   investments

 

 

 

 

 

 

 

 

 

 

 

 

 

2

 

 

 

 

 

 

2

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,393

)

 

 

(8,393

)

Balance at September 30, 2020

 

 

25,808

 

 

$

26

 

 

$

649,897

 

 

 

 

$

1

 

 

$

(609,701

)

 

$

40,223

 

 

6


AVEO PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

(In thousands)

(Unaudited)

 

 

 

Common Shares

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Par Value

 

 

Additional

Paid-in

Capital

 

 

 

 

Accumulated

Other

Comprehensive

Income

 

 

Accumulated

Deficit

 

 

Total

Stockholders'

Equity (Deficit)

 

Balance at December 31, 2018

 

 

12,648

 

 

$

13

 

 

$

567,768

 

 

 

 

$

1

 

 

$

(595,009

)

 

$

(27,227

)

Issuance of common stock from the

   SVB Leerink sales agreement

   (net of issuance costs of $0.2

   million)

 

 

1,252

 

 

 

1

 

 

 

7,511

 

 

 

 

 

 

 

 

 

 

 

7,512

 

Stock-based compensation expense

   related to equity-classified awards

 

 

 

 

 

 

 

 

584

 

 

 

 

 

 

 

 

 

 

 

584

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

555

 

 

 

555

 

Balance at March 31, 2019

 

 

13,900

 

 

$

14

 

 

$

575,863

 

 

 

 

$

1

 

 

$

(594,454

)

 

$

(18,576

)

Issuance of common stock and

   warrants in a public offering,

   excluding to related parties

   (net of issuance costs of

   $2.3 million)

 

 

1,739

 

 

 

2

 

 

 

17,765

 

 

 

 

 

 

 

 

 

 

 

17,767