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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, 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)
(857) 400-0101
(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 August 7, 2020: 25,808,315.
AVEO PHARMACEUTICALS, INC.
FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2020
TABLE OF CONTENTS
2
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(In thousands, except par value amounts)
(Unaudited)
|
|
June 30,
2020 |
|
|
December 31,
2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
45,670 |
|
|
$ |
29,785 |
|
Marketable securities |
|
|
25,779 |
|
|
|
17,960 |
|
Accounts receivable |
|
|
1,208 |
|
|
|
1,631 |
|
Clinical trial retainers |
|
|
524 |
|
|
|
589 |
|
Other prepaid expenses and other current assets |
|
|
1,047 |
|
|
|
635 |
|
Total current assets |
|
|
74,228 |
|
|
|
50,600 |
|
Property and equipment, net |
|
|
96 |
|
|
|
— |
|
Operating lease right-of-use asset |
|
|
1,120 |
|
|
|
— |
|
Other assets |
|
|
158 |
|
|
|
— |
|
Total assets |
|
$ |
75,602 |
|
|
$ |
50,600 |
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,785 |
|
|
$ |
1,466 |
|
Accrued clinical trial costs and contract research |
|
|
5,000 |
|
|
|
5,680 |
|
Other accrued liabilities |
|
|
2,121 |
|
|
|
2,336 |
|
Operating lease liability |
|
|
451 |
|
|
|
— |
|
Loans payable, net of discount |
|
|
10,193 |
|
|
|
9,569 |
|
Deferred revenue |
|
|
1,974 |
|
|
|
1,974 |
|
Deferred research and development reimbursements |
|
|
259 |
|
|
|
93 |
|
Total current liabilities |
|
|
21,783 |
|
|
|
21,118 |
|
Loans payable, net of current portion and discount |
|
|
940 |
|
|
|
6,197 |
|
Deferred revenue |
|
|
1,565 |
|
|
|
2,552 |
|
PIPE Warrant liability (Note 7) |
|
|
1,999 |
|
|
|
5,097 |
|
Operating lease liability, non-current |
|
|
473 |
|
|
|
— |
|
Other liabilities (Note 6) |
|
|
790 |
|
|
|
790 |
|
Total liabilities |
|
|
27,550 |
|
|
|
35,754 |
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $.001 par value: 5,000 shares authorized at June 30,
2020 and December 31, 2019; no shares issued and outstanding at each of
June 30, 2020 and December 31, 2019 |
|
|
— |
|
|
|
— |
|
Common stock, $.001 par value: 50,000 shares authorized at June 30,
2020 and December 31, 2019; 25,808 shares issued and outstanding at
June 30, 2020 and 16,081 issued and outstanding at December 31, 2019 |
|
|
26 |
|
|
|
16 |
|
Additional paid-in capital |
|
|
649,335 |
|
|
|
600,451 |
|
Accumulated other comprehensive loss |
|
|
(1 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(601,308 |
) |
|
|
(585,621 |
) |
Total stockholders’ equity |
|
|
48,052 |
|
|
|
14,846 |
|
Total liabilities and stockholders’ equity |
|
$ |
75,602 |
|
|
$ |
50,600 |
|
See accompanying notes.
3
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, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and licensing revenue |
|
$ |
494 |
|
|
$ |
493 |
|
|
$ |
987 |
|
|
$ |
1,947 |
|
Partnership royalties |
|
|
255 |
|
|
|
210 |
|
|
|
546 |
|
|
|
367 |
|
|
|
|
749 |
|
|
|
703 |
|
|
|
1,533 |
|
|
|
2,314 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
4,419 |
|
|
|
2,611 |
|
|
|
12,245 |
|
|
|
9,463 |
|
General and administrative |
|
|
3,737 |
|
|
|
2,986 |
|
|
|
7,409 |
|
|
|
5,441 |
|
|
|
|
8,156 |
|
|
|
5,597 |
|
|
|
19,654 |
|
|
|
14,904 |
|
Loss from operations |
|
|
(7,407 |
) |
|
|
(4,894 |
) |
|
|
(18,121 |
) |
|
|
(12,590 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
|
(349 |
) |
|
|
(451 |
) |
|
|
(664 |
) |
|
|
(1,015 |
) |
Change in fair value of PIPE Warrant liability |
|
|
450 |
|
|
|
2,210 |
|
|
|
3,098 |
|
|
|
11,025 |
|
Other income (expense), net |
|
|
101 |
|
|
|
1,759 |
|
|
|
2,434 |
|
|
|
10,010 |
|
Net loss |
|
$ |
(7,306 |
) |
|
$ |
(3,135 |
) |
|
$ |
(15,687 |
) |
|
$ |
(2,580 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.42 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.18 |
) |
Weighted average number of common shares outstanding |
|
|
17,364 |
|
|
|
15,902 |
|
|
|
16,722 |
|
|
|
14,574 |
|
See accompanying notes.
4
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Comprehensive Loss
(In thousands)
(Unaudited)
|
|
Three Months Ended
June 30, |
|
|
Six Months Ended
June 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Net loss |
|
$ |
(7,306 |
) |
|
$ |
(3,135 |
) |
|
$ |
(15,687 |
) |
|
$ |
(2,580 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities |
|
|
(1 |
) |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(7,307 |
) |
|
$ |
(3,135 |
) |
|
$ |
(15,688 |
) |
|
$ |
(2,580 |
) |
See accompanying notes.
5
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 |
|
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 |
|
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 |
|
Issuance of common stock and
warrants in a public offering,
to related parties |
|
|
435 |
|
|
|
— |
|
|
|
5,000 |
|
|
|
— |
|
|
|
— |
|
|
|
5,000 |
|
Stock-based compensation expense
related to equity-classified awards |
|
|
— |
|
|
|
— |
|
|
|
584 |
|
|
|
— |
|
|
|
— |
|
|
|
584 |
|
Exercise of stock options |
|
|
— |
|
|
|
— |
|
|
|
3 |
|
|
|
— |
|
|
|
— |
|
|
|
3 |
|
Net loss |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(3,135 |
) |
|
|
(3,135 |
) |
Balance at June 30, 2019 |
|
|
16,074 |
|
|
$ |
16 |
|
|
$ |
599,215 |
|
|
$ |
1 |
|
|
$ |
(597,589 |
) |
|
$ |
1,643 |
|
7
AVEO PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
Six Months Ended
June 30, |
|
|
|
2020 |
|
|
2019 |
|
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(15,687 |
) |
|
$ |
(2,580 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and Amortization |
|
|
4 |
|
|
|
— |
|
Stock-based compensation |
|
|
1,121 |
|
|
|
1,168 |
|
Non-cash interest expense |
|
|
200 |
|
|
|
311 |
|
Non-cash change in fair value of PIPE Warrant liability |
|
|
(3,098 |
) |
|
|
(11,025 |
) |
Amortization of premium and discount on investments |
|
|
(81 |
) |
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
423 |
|
|
|
2,415 |
|
Prepaid expenses and other current assets |
|
|
(347 |
) |
|
|
— |
|
Operating lease right-of-use asset |
|
|
(1,278 |
) |
|
|
(337 |
) |
Accounts payable |
|
|
319 |
|
|
|
(1,536 |
) |
Accrued contract research |
|
|
(680 |
) |
|
|
(1,546 |
) |
Other accrued liabilities |
|
|
(215 |
) |
|
|
(1,143 |
) |
Other current liabilities |
|
|
451 |
|
|
|
— |
|
Deferred revenue |
|
|
(987 |
) |
|
|
53 |
|
Deferred research and development reimbursements |
|