10-Q
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

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

For the quarterly period ended September 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: 001-40655

 

ICOSAVAX, INC.

(Exact name of Registrant as specified in its charter)

 

 

Delaware

 

82-3640549

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

 

 

 

1616 Eastlake Avenue E., Suite 208

Seattle, Washington

 

98102

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (206) 737-0085

 

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, $0.0001 par value per share

 

ICVX

 

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 November 12, 2021, the registrant had 39,041,805 shares of common stock ($0.0001 par value) outstanding.

 


 

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

 

Item 1

 

Financial Statements (Unaudited)

3

 

 

Condensed Balance Sheets

3

 

 

Condensed Statements of Operations

4

 

 

Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

5

 

 

Condensed Statements of Cash Flows

6

 

 

Notes to Unaudited Condensed Financial Statements

7

Item 2

 

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

19

Item 3

 

Quantitative and Qualitative Disclosures About Market Risk

27

Item 4

 

Controls and Procedures

27

 

PART II. OTHER INFORMATION

 

Item 1

 

Legal Proceedings

28

Item 1A

 

Risk Factors

28

Item 2

 

Unregistered Sales of Equity Securities and Use of Proceeds

74

Item 3

 

Defaults Upon Senior Securities

75

Item 4

 

Mine Safety Disclosures

75

Item 5

 

Other Information

75

Item 6

 

Exhibits

75

 

 

Exhibit Index

75

 

 

Signatures

77

 

 


 

 

 

 


 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements (unaudited)

ICOSAVAX, INC.

Condensed Balance Sheets

(in thousands, except share and par value data)

 

 

 

September 30,

 

 

December 31,

 

 

 

 

 

 

 

 

2021

 

 

2020

 

 

 

(Unaudited)

 

 

(Note 2)

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash

 

$

291,271

 

 

$

13,114

 

Restricted cash

 

 

2,652

 

 

 

2,384

 

Prepaid expenses and other current assets

 

 

6,353

 

 

 

662

 

Total current assets

 

 

300,276

 

 

 

16,160

 

Property and equipment, net

 

 

548

 

 

 

10

 

Total assets

 

$

300,824

 

 

$

16,170

 

Liabilities, convertible preferred stock, and stockholders' equity (deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

3,049

 

 

$

1,918

 

Accrued and other current liabilities

 

 

2,487

 

 

 

1,532

 

Deferred revenue

 

 

2,652

 

 

 

2,384

 

Total current liabilities

 

 

8,188

 

 

 

5,834

 

Long-term convertible promissory note

 

 

 

 

 

4,947

 

Embedded derivative liability

 

 

 

 

 

1,604

 

Other noncurrent liabilities

 

 

197

 

 

 

426

 

Total liabilities

 

 

8,385

 

 

 

12,811

 

Commitments and contingencies (Note 2)

 

 

 

 

 

 

Convertible preferred stock, $0.0001 par value; no shares authorized at September 30, 2021 and 54,039,749 shares authorized at December 31, 2020; no shares issued and outstanding at September 30, 2021 and 32,198,879 shares issued and outstanding at December 31, 2020; $0 and $30,007 aggregate liquidation preference at September 30, 2021 and December 31, 2020, respectively

 

 

 

 

 

30,062

 

Stockholders' equity (deficit):

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 50,000,000 and no shares authorized at September 30, 2021 and December 31, 2020, respectively; no shares issued and outstanding at September 30, 2021 and December 31, 2020

 

 

 

 

 

 

Common stock, $0.0001 par value; 500,000,000 and 78,000,000 shares authorized at September 30, 2021 and December 31, 2020, respectively; 39,387,389 and 3,596,936 shares issued at September 30, 2021 and December 31, 2020, respectively; 38,991,403 and 2,639,026 shares outstanding at September 30, 2021 and December 31, 2020, respectively

 

 

5

 

 

 

2

 

Additional paid-in capital

 

 

368,321

 

 

 

393

 

Accumulated deficit

 

 

(75,887

)

 

 

(27,098

)

Total stockholders' equity (deficit)

 

 

292,439

 

 

 

(26,703

)

Total liabilities, convertible preferred stock and stockholders' equity (deficit)

 

$

300,824

 

 

$

16,170

 

 

See accompanying notes to financial statements

 

 

 

3


 

ICOSAVAX, INC.

Condensed Statements of Operations and Comprehensive Loss

(Unaudited)

(in thousands, except share and per share data)

 

 

 

 

Three Months Ended
September 30,

 

 

Nine Months Ended
September 30,

 

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Grant revenue

 

$

1,827

 

 

$

 

 

$

5,732

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

 

10,883

 

 

 

4,752

 

 

 

24,713

 

 

 

12,338

 

General and administrative

 

 

 

25,357

 

 

 

704

 

 

 

28,669

 

 

 

1,857

 

Total operating expenses

 

 

 

36,240

 

 

 

5,456

 

 

 

53,382

 

 

 

14,195

 

Loss from operations

 

 

 

(34,413

)

 

 

(5,456

)

 

 

(47,650

)

 

 

(14,195

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of embedded derivative liability

 

 

 

-

 

 

 

-

 

 

 

(205

)

 

 

-

 

Loss on extinguishment of convertible promissory note

 

 

 

-

 

 

 

-

 

 

 

(754

)

 

 

-

 

Interest and other income (expense)

 

 

 

27

 

 

 

(121

)

 

 

(180

)

 

 

(51

)

Total other income (expense)

 

 

 

27

 

 

 

(121

)

 

 

(1,139

)

 

 

(51

)

Net loss and comprehensive loss

 

 

$

(34,386

)

 

$

(5,577

)

 

$

(48,789

)

 

$

(14,246

)

Net loss per share, basic and diluted

 

 

$

(1.30

)

 

$

(2.40

)

 

$

(4.50

)

 

$

(6.66

)

Weighted-average common shares outstanding, basic and diluted

 

 

26,494,914

 

 

 

2,321,765

 

 

 

10,836,894

 

 

 

2,139,768

 

 

See accompanying notes to financial statements

 

 

 

4


 

ICOSAVAX, INC.

Condensed Statements of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

(Unaudited)

(in thousands, except share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Stockholders'

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Equity

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

(Deficit)

 

 Balance at December 31, 2020

 

 

32,198,879

 

 

$

30,062

 

 

 

 

2,639,026

 

 

$

2

 

 

$

393

 

 

$

(27,098

)

 

$

(26,703

)

 Issuance of Series A-1 convertible preferred stock
   for cash of $
0.9615 per share net of
   $
0.1 million of issuance costs

 

 

21,944,874

 

 

 

21,005

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Issuance of Series B-1 convertible preferred stock
   for cash of $
2.82172 per share net of
   $
0.3 million in issuance costs

 

 

32,958,612

 

 

 

92,654

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Issuance of Series B-2 convertible preferred stock
   from convertible note

 

 

2,805,850

 

 

 

7,917

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Shares released from restriction upon vesting of
   early-exercised stock options

 

 

 

 

 

 

 

 

 

100,238

 

 

 

 

 

 

63

 

 

 

 

 

 

63

 

 Exercise of common stock options

 

 

 

 

 

 

 

 

 

35,143

 

 

 

 

 

 

29

 

 

 

 

 

 

29

 

 Vesting of shares of restricted common stock

 

 

 

 

 

 

 

 

 

117,369

 

 

 

 

 

 

 

 

 

 

 

 

 

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

276

 

 

 

 

 

 

276

 

 Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,851

)

 

 

(5,851

)

 Balance at March 31, 2021

 

 

89,908,215

 

 

 

151,638

 

 

 

 

2,891,776

 

 

 

2

 

 

 

761

 

 

 

(32,949

)

 

 

(32,186

)

 Issuance costs incurred related to Series A-1
   convertible preferred stock

 

 

 

 

 

(1

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Issuance costs incurred related to Series B-1
   convertible preferred stock

 

 

 

 

 

(24

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Shares released from restriction upon vesting of
   early-exercised stock options

 

 

 

 

 

 

 

 

 

63,257

 

 

 

 

 

 

32

 

 

 

 

 

 

32

 

 Vesting of shares of restricted common stock

 

 

 

 

 

 

 

 

 

117,369

 

 

 

 

 

 

 

 

 

 

 

 

 

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,408

 

 

 

 

 

 

1,408

 

 Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,552

)

 

 

(8,552

)

 Balance at June 30, 2021

 

 

89,908,215

 

 

 

151,613

 

 

 

 

3,072,402

 

 

 

2

 

 

 

2,201

 

 

 

(41,501

)

 

 

(39,298

)

 Initial public offering, net of issuance costs of $18.6 million

 

 

 

 

 

 

 

 

 

13,953,332

 

 

 

1

 

 

 

190,709

 

 

 

 

 

 

190,710

 

 Conversion of convertible preferred stock into common stock

 

 

(89,908,215

)

 

 

(151,613

)

 

 

 

21,634,898

 

 

 

2

 

 

 

151,611

 

 

 

 

 

 

151,613

 

 Stock- based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

23,670

 

 

 

 

 

 

23,670

 

 Vesting of shares of restricted common stock

 

 

 

 

 

 

 

 

 

148,743

 

 

 

 

 

 

 

 

 

 

 

 

 

 Shares released from restriction upon vesting of
   early-exercised stock options

 

 

 

 

 

 

 

 

 

124,536

 

 

 

 

 

 

82

 

 

 

 

 

 

82

 

 Exercise of stock options

 

 

 

 

 

 

 

 

 

57,492

 

 

 

 

 

 

48

 

 

 

 

 

 

48

 

 Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,386

)

 

 

(34,386

)

 Balance at September 30, 2021

 

 

-

 

 

$

-

 

 

 

 

38,991,403

 

 

$

5

 

 

$

368,321

 

 

$

(75,887

)

 

$

292,439

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

Deficit

 

 Balance at December 31, 2019

 

 

32,198,879

 

 

$

30,062

 

 

 

 

1,901,656

 

 

$

1

 

 

$

 

 

$

(8,244

)

 

$

(8,243

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Shares released from restriction upon vesting of
   early-exercised stock options

 

 

 

 

 

 

 

 

 

25,641

 

 

 

 

 

 

1

 

 

 

 

 

 

1

 

 Vesting of shares of restricted common stock

 

 

 

 

 

 

 

 

 

117,369

 

 

 

 

 

 

 

 

 

 

 

 

 

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

54

 

 

 

 

 

 

54

 

 Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,471

)

 

 

(3,471

)

 Balance at March 31, 2020

 

 

32,198,879

 

 

 

30,062

 

 

 

 

2,044,666

 

 

 

1

 

 

 

55

 

 

 

(11,715

)

 

 

(11,659

)

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

63

 

 

 

 

 

 

63

 

 Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,198

)

 

 

(5,198

)

 Balance at June 30, 2020

 

 

32,198,879

 

 

 

30,062

 

 

 

 

2,044,666

 

 

 

1

 

 

 

118

 

 

 

(16,913

)

 

 

(16,794

)

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

70

 

 

 

 

 

 

70

 

 Shares released from restriction upon vesting of
   early-exercised stock options

 

 

 

 

 

 

 

 

 

117,381

 

 

 

1

 

 

 

108

 

 

 

 

 

 

109

 

 Vesting of shares of restricted common stock

 

 

 

 

 

 

 

 

 

125,728

 

 

 

 

 

 

 

 

 

 

 

 

 

 Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(5,577

)

 

 

(5,577

)

 Balance at September 30, 2020

 

 

32,198,879

 

 

$

30,062

 

 

 

 

2,287,775

 

 

$

2

 

 

$

296

 

 

$

(22,490

)

 

$

(22,192

)

 

 

See accompanying notes to financial statements

 

5


 

ICOSAVAX, INC.

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

 

 Nine Months Ended
September 30,

 

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

Operating activities:

 

 

 

 

 

 

Net loss

 

$

(48,789

)

 

$

(14,246

)

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

 

 

 

 

 

 

Stock-based compensation

 

 

25,354