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, 2023

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 8, 2023, the registrant had 50,090,341 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 Stockholders’ Equity

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

20

Item 3

Quantitative and Qualitative Disclosures About Market Risk

28

Item 4

Controls and Procedures

28

 

PART II. OTHER INFORMATION

 

Item 1

Legal Proceedings

29

Item 1A

Risk Factors

29

Item 2

Unregistered Sales of Equity Securities and Use of Proceeds

79

Item 3

Defaults Upon Senior Securities

79

Item 4

Mine Safety Disclosures

79

Item 5

Other Information

79

Item 6

Exhibits

79

 

 

Signatures

81

 

 


 

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,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

63,239

 

 

$

58,846

 

Restricted cash

 

 

 

 

 

1,061

 

Short-term investments

 

 

165,967

 

 

 

159,461

 

Prepaid expenses and other current assets

 

 

6,101

 

 

 

4,545

 

Total current assets

 

 

235,307

 

 

 

223,913

 

Right-of-use assets – operating leases

 

 

2,975

 

 

 

3,247

 

Property and equipment, net

 

 

11,400

 

 

 

11,517

 

Other noncurrent assets

 

 

1,614

 

 

 

 

Total assets

 

$

251,296

 

 

$

238,677

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,239

 

 

$

2,892

 

Accrued and other current liabilities

 

 

9,606

 

 

 

8,759

 

Current portion of operating lease liabilities

 

 

2,185

 

 

 

2,137

 

Total current liabilities

 

 

13,030

 

 

 

13,788

 

Operating lease liabilities, net of current portion

 

 

5,886

 

 

 

6,658

 

Other noncurrent liabilities

 

 

 

 

 

69

 

Total liabilities

 

 

18,916

 

 

 

20,515

 

Commitments and contingencies (Note 2)

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

Common stock, $0.0001 par value; 500,000,000 shares authorized at September 30, 2023 and December 31, 2022; 50,088,633 and 41,177,706 shares issued as of September 30, 2023 and December 31, 2022, respectively; 50,088,633 and 41,095,564 shares outstanding as of September 30, 2023 and December 31, 2022, respectively

 

 

7

 

 

 

6

 

Additional paid-in capital

 

 

491,347

 

 

 

404,386

 

Accumulated other comprehensive loss

 

 

(48

)

 

 

(403

)

Accumulated deficit

 

 

(258,926

)

 

 

(185,827

)

Total stockholders' equity

 

 

232,380

 

 

 

218,162

 

Total liabilities and stockholders' equity

 

$

251,296

 

 

$

238,677

 

 

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,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Grant revenue

 

$

 

 

$

 

 

$

 

 

$

582

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

16,668

 

 

 

15,484

 

 

 

53,851

 

 

 

49,217

 

General and administrative

 

 

8,607

 

 

 

7,659

 

 

 

26,901

 

 

 

21,292

 

Total operating expenses

 

 

25,275

 

 

 

23,143

 

 

 

80,752

 

 

 

70,509

 

Loss from operations

 

 

(25,275

)

 

 

(23,143

)

 

 

(80,752

)

 

 

(69,927

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other income

 

 

3,234

 

 

 

1,167

 

 

 

7,653

 

 

 

1,782

 

Total other income

 

 

3,234

 

 

 

1,167

 

 

 

7,653

 

 

 

1,782

 

Net loss

 

$

(22,041

)

 

$

(21,976

)

 

$

(73,099

)

 

$

(68,145

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gains (losses) on available-for-sale debt securities

 

 

18

 

 

 

(334

)

 

 

355

 

 

 

(609

)

Comprehensive loss

 

$

(22,023

)

 

$

(22,310

)

 

$

(72,744

)

 

$

(68,754

)

Net loss per share, basic and diluted

 

$

(0.44

)

 

$

(0.55

)

 

$

(1.61

)

 

$

(1.72

)

Weighted-average common shares outstanding, basic and diluted

 

 

50,030,759

 

 

 

39,748,984

 

 

 

45,411,654

 

 

 

39,623,357

 

 

See accompanying notes to financial statements

 

 

3


 

ICOSAVAX, INC.

Condensed Statements of Stockholders’ Equity

(Unaudited)

(in thousands, except share amounts)

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Loss

 

 

Deficit

 

 

Equity

 

 Balance at December 31, 2022

 

 

41,095,564

 

 

$

6

 

 

$

404,386

 

 

$

(403

)

 

$

(185,827

)

 

$

218,162

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

30,392

 

 

 

 

 

 

25

 

 

 

 

 

 

 

 

 

25

 

 Exercise of common stock options

 

 

109,913

 

 

 

 

 

 

117

 

 

 

 

 

 

 

 

 

117

 

 Vesting of shares of restricted common stock

 

 

110,021

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Stock-based compensation

 

 

 

 

 

 

 

 

6,000

 

 

 

 

 

 

 

 

 

6,000

 

 Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

340

 

 

 

 

 

 

340

 

 Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(24,561

)

 

 

(24,561

)

 Balance at March 31, 2023

 

 

41,345,890

 

 

$

6

 

 

$

410,528

 

 

$

(63

)

 

$

(210,388

)

 

$

200,083

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Issuance of common stock

 

 

8,369,754

 

 

 

1

 

 

 

67,480

 

 

 

 

 

 

 

 

 

67,481

 

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

 

 

30,390

 

 

 

 

 

 

26

 

 

 

 

 

 

 

 

 

26

 

 Exercise of common stock options

 

 

35,805

 

 

 

 

 

 

65

 

 

 

 

 

 

 

 

 

65

 

 Vesting of shares of restricted common stock

 

 

42,941

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Issuance of common stock for Employee Stock Purchase Plan

 

 

91,440

 

 

 

 

 

 

256

 

 

 

 

 

 

 

 

 

256

 

 Stock-based compensation

 

 

 

 

 

 

 

 

6,311

 

 

 

 

 

 

 

 

 

6,311

 

 Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

 Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26,497

)

 

 

(26,497

)

 Balance at June 30, 2023

 

 

49,916,220

 

 

$

7

 

 

$

484,666

 

 

$

(66

)

 

$

(236,885

)

 

$

247,722

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

21,360

 

 

 

 

 

 

18

 

 

 

 

 

 

 

 

 

18

 

 Exercise of common stock options

 

 

36,436

 

 

 

 

 

 

61

 

 

 

 

 

 

 

 

 

61

 

 Vesting of shares of restricted common stock

 

 

114,617

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 Stock-based compensation

 

 

 

 

 

 

 

 

6,602

 

 

 

 

 

 

 

 

 

6,602

 

 Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

18

 

 

 

 

 

 

18

 

 Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,041

)

 

 

(22,041

)

 Balance at September 30, 2023

 

 

50,088,633

 

 

$

7

 

 

$

491,347

 

 

$

(48

)

 

$

(258,926

)

 

$

232,380

 

 

 

4


 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Additional

 

 

Other

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Paid-in

 

 

Comprehensive

 

 

Accumulated

 

 

Stockholders'

 

 

 

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

 

 

See accompanying notes to financial statements

 

 

5


 

ICOSAVAX, INC.

Condensed Statements of Cash Flows

(Unaudited)

(in thousands)

 

 

 

Nine Months Ended
September 30,

 

 

 

2023

 

 

2022

 

Operating activities:

 

 

 

 

 

 

Net loss

 

$

(73,099

)

 

$

(68,145

)

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

 

 

 

 

 

 

Stock-based compensation

 

 

18,913

 

 

 

15,536

 

Depreciation

 

 

2,071

 

 

 

241

 

Non-cash lease expense

 

 

 

 

 

721

 

Amortization of premiums and discounts on short-term investments

 

 

(3,630

)

 

 

(730

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaids and other current assets

 

 

(1,936

)

 

 

(21

)

Right-of-use assets – operating leases

 

 

272

 

 

 

 

Other noncurrent assets

 

 

(1,234

)

 

 

 

Accounts payable

 

 

(1,323

)

 

 

(1,594

)

Accrued and other current liabilities

 

 

847

 

 

 

1,903

 

Deferred revenue

 

 

 

 

 

(582

)

Operating lease liabilities

 

 

(1,254

)

 

 

 

Proceeds from lease incentive

 

 

530

 

 

 

2,629

 

Net cash used in operating activities

 

 

(59,843

)

 

 

(50,042

)

Investing activities:

 

 

 

 

 

 

Purchases of property and equipment

 

 

(2,284

)

 

 

(8,563

)

Purchases of short-term investments

 

 

(162,372

)

 

 

(171,023

)

Maturities of short-term investments

 

 

159,851

 

 

 

14,250

 

Net cash used in investing activities

 

 

(4,805

)

 

 

(165,336

)

Financing activities:

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

67,481

 

 

 

 

Proceeds from exercise of stock options

 

 

499

 

 

 

582

 

Payment of deferred offering costs

 

 

 

 

 

(362

)

Net cash provided by financing activities

 

 

67,980

 

 

 

220