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, 2022

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.)

 

 

 

1930 Boren Avenue, Suite 1000

Seattle, Washington

 

98101

(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 10, 2022, the registrant had 39,900,403 shares of common stock ($0.0001 par value) outstanding.

 


 

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

 

Item 1

 

Financial Statements (Unaudited)

2

 

 

Condensed Balance Sheets

2

 

 

Condensed Statements of Operations and Comprehensive Loss

3

 

 

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

4

 

 

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

22

Item 3

 

Quantitative and Qualitative Disclosures About Market Risk

31

Item 4

 

Controls and Procedures

31

 

PART II. OTHER INFORMATION

 

Item 1

 

Legal Proceedings

32

Item 1A

 

Risk Factors

32

Item 2

 

Unregistered Sales of Equity Securities and Use of Proceeds

81

Item 3

 

Defaults Upon Senior Securities

81

Item 4

 

Mine Safety Disclosures

81

Item 5

 

Other Information

81

Item 6

 

Exhibits

82

 

 

Signatures

83

 

 


 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

ICOSAVAX, INC.

Condensed Balance Sheets

(Unaudited)

(in thousands, except share and par value data)

 

 

 

September 30,

 

 

December 31,

 

 

 

2022

 

 

2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

64,505

 

 

$

279,082

 

Restricted cash

 

 

1,061

 

 

 

1,642

 

Short-term investments

 

 

156,894

 

 

 

 

Prepaid expenses and other current assets

 

 

6,272

 

 

 

5,829

 

Total current assets

 

 

228,732

 

 

 

286,553

 

Right-of-use assets – operating leases

 

 

3,330

 

 

 

 

Property and equipment, net

 

 

11,815

 

 

 

1,076

 

Total assets

 

$

243,877

 

 

$

287,629

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

4,722

 

 

$

3,899

 

Accrued and other current liabilities

 

 

6,720

 

 

 

4,757

 

Current portion of operating lease liabilities

 

 

1,591

 

 

 

 

Deferred revenue

 

 

 

 

 

582

 

Total current liabilities

 

 

13,033

 

 

 

9,238

 

Operating lease liabilities, net of current portion

 

 

5,089

 

 

 

 

Other noncurrent liabilities

 

 

93

 

 

 

171

 

Total liabilities

 

 

18,215

 

 

 

9,409

 

Commitments and contingencies (Note 2)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Common stock, $0.0001 par value; 500,000,000 shares authorized at September 30, 2022 and December 31, 2021; 39,900,403 and 39,429,103 shares issued as of September 30, 2022 and December 31, 2021, respectively; 39,787,364 and 39,175,279 shares outstanding as of September 30, 2022 and December 31, 2021, respectively

 

 

5

 

 

 

5

 

Additional paid-in capital

 

 

388,480

 

 

 

372,284

 

Accumulated other comprehensive loss

 

 

(609

)

 

 

 

Accumulated deficit

 

 

(162,214

)

 

 

(94,069

)

Total stockholders' equity

 

 

225,662

 

 

 

278,220

 

Total liabilities and stockholders' equity

 

$

243,877

 

 

$

287,629

 

 

See accompanying notes to financial statements

 

 

 


 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Grant revenue

 

$

 

 

$

1,827

 

 

$

582

 

 

$

5,732

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

15,484

 

 

 

10,883

 

 

 

49,217

 

 

 

24,713

 

General and administrative

 

 

7,659

 

 

 

25,357

 

 

 

21,292

 

 

 

28,669

 

Total operating expenses

 

 

23,143

 

 

 

36,240

 

 

 

70,509

 

 

 

53,382

 

Loss from operations

 

 

(23,143

)

 

 

(34,413

)

 

 

(69,927

)

 

 

(47,650

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Change in fair value of embedded derivative liability

 

 

 

 

 

 

 

 

 

 

 

(205

)

Loss on extinguishment of convertible promissory note

 

 

 

 

 

 

 

 

 

 

 

(754

)

Interest and other

 

 

1,167

 

 

 

27

 

 

 

1,782

 

 

 

(180

)

Total other income (expense)

 

 

1,167

 

 

 

27

 

 

 

1,782

 

 

 

(1,139

)

Net loss

 

$

(21,976

)

 

$

(34,386

)

 

$

(68,145

)

 

$

(48,789

)

Comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized losses on available-for-sale debt securities

 

 

(334

)

 

 

 

 

 

(609

)

 

 

 

Comprehensive loss

 

$

(22,310

)

 

$

(34,386

)

 

$

(68,754

)

 

$

(48,789

)

Net loss per share, basic and diluted

 

$

(0.55

)

 

$

(1.30

)

 

$

(1.72

)

 

$

(4.50

)

Weighted-average common shares outstanding, basic and diluted

 

 

39,748,984

 

 

 

26,494,914

 

 

 

39,623,357

 

 

 

10,836,894

 

 

See accompanying notes to financial statements

 

 

3


 

ICOSAVAX, INC.

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

(Unaudited)

(in thousands, except share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Other Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

 Balance at December 31, 2021

 

 

 

 

$

 

 

 

 

39,175,279

 

 

$

5

 

 

$

372,284

 

 

$

 

 

$

(94,069

)

 

$

278,220

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

53,483

 

 

 

 

 

 

27

 

 

 

 

 

 

 

 

 

27

 

 Exercise of common stock options

 

 

 

 

 

 

 

 

 

295,764

 

 

 

 

 

 

276

 

 

 

 

 

 

 

 

 

276

 

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,550

 

 

 

 

 

 

 

 

 

4,550

 

 Net loss and comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(23,533

)

 

 

(23,533

)

 Balance at March 31, 2022

 

 

 

 

$

 

 

 

 

39,524,526

 

 

$

5

 

 

$

377,137

 

 

$

 

 

$

(117,602

)

 

$

259,540

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

52,208

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

25

 

 Exercise of common stock options

 

 

 

 

 

 

 

 

 

1,962

 

 

 

 

 

 

12

 

 

 

 

 

 

 

 

 

12

 

 Vesting of shares of restricted common stock

 

 

 

 

 

 

 

 

 

14,916

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Issuance of common stock for Employee Stock Purchase Plan

 

 

 

 

 

 

 

 

 

36,785

 

 

 

 

 

 

211

 

 

 

 

 

 

 

 

 

211

 

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,552

 

 

 

 

 

 

 

 

 

5,552

 

 Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(275

)

 

 

 

 

 

(275

)

 Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,636

)

 

 

(22,636

)

 Balance at June 30, 2022

 

 

 

 

$

 

 

 

 

39,630,397

 

 

$

5

 

 

$

382,937

 

 

$

(275

)

 

$

(140,238

)

 

$

242,429

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

 

 

 

 

 

 

 

35,094

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

25

 

 Exercise of common stock options

 

 

 

 

 

 

 

 

 

26,226

 

 

 

 

 

 

84

 

 

 

 

 

 

 

 

 

84

 

 Vesting of shares of restricted common stock

 

 

 

 

 

 

 

 

 

95,647

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Stock-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,434

 

 

 

 

 

 

 

 

 

5,434

 

 Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(334

)

 

 

 

 

 

(334

)

 Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,976

)

 

 

(21,976

)

 Balance at September 30, 2022

 

 

 

 

$

 

 

 

 

39,787,364

 

 

$

5

 

 

$

388,480

 

 

$

(609

)

 

$

(162,214

)

 

$

225,662

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Accumulated

 

 

 

 

 

Total

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Paid-in

 

 

Other Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

(Deficit) Equity

 

 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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4


 

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

 

 

 

 

 

 

 

 

 

100,238

 

 

 

 

 

 

63

 

 

 

 

 

 

 

 

 

63

 

 Exercise of common stock options

 

 

 

 

 

 

 

 

 

35,143

 

 

 

 

 

 

29

 

 

 

 

 

 

 

 

 

29