10-Q
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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, 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: 001-40703

 

INVIVYD, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

85-1403134

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

1601 Trapelo Road, Suite 178
Waltham, MA

02451

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (781) 819-0080

 

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

 

IVVD

 

The Nasdaq Global 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 2, 2023, the registrant had 110,114,960 shares of common stock, $0.0001 par value per share, outstanding.

 

 


Table of Contents

Page

PART I.

FINANCIAL INFORMATION

1

Item 1.

Financial Statements (Unaudited)

1

Condensed Consolidated Balance Sheets

1

Condensed Consolidated Statements of Operations and Comprehensive Loss

2

Condensed Consolidated Statements of Stockholders’ Equity (Deficit)

3

Condensed Consolidated Statements of Cash Flows

4

Notes to Unaudited Condensed Consolidated Financial Statements

5

Item 2.

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

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

37

Item 4.

Controls and Procedures

37

PART II.

OTHER INFORMATION

38

Item 1.

Legal Proceedings

38

Item 1A.

Risk Factors

38

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

38

Item 6.

Exhibits

39

Signatures

40

 

i


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

INVIVYD, INC.

Condensed Consolidated Balance Sheets

(UNaudited)

(In thousands, except share and per share amounts)

 

 

September 30,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

181,822

 

 

$

92,076

 

Marketable securities

 

 

83,063

 

 

 

279,915

 

Prepaid expenses and other current assets

 

 

5,218

 

 

 

4,926

 

Total current assets

 

 

270,103

 

 

 

376,917

 

Property and equipment, net

 

 

2,002

 

 

 

2,282

 

Operating lease right-of-use assets

 

 

2,625

 

 

 

3,777

 

Other non-current assets

 

 

187

 

 

 

191

 

Total assets

 

$

274,917

 

 

$

383,167

 

Liabilities, Preferred Stock and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

9,168

 

 

$

1,517

 

Accrued expenses

 

 

15,958

 

 

 

21,911

 

Operating lease liabilities, current

 

 

1,638

 

 

 

1,559

 

Other current liabilities

 

 

27

 

 

 

44

 

Total current liabilities

 

 

26,791

 

 

 

25,031

 

Operating lease liabilities, non-current

 

 

927

 

 

 

2,165

 

Other non-current liability

 

 

700

 

 

 

 

Early-exercise liability

 

 

 

 

 

1

 

Total liabilities

 

 

28,418

 

 

 

27,197

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

        Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares
           authorized and
no shares issued and outstanding at September 30, 2023
           and December 31, 2022

 

 

 

 

 

 

        Common stock, $0.0001 par value; 1,000,000,000 shares authorized,
           
109,846,329 shares issued and outstanding at September 30, 2023;
           
109,044,046 shares issued and outstanding at December 31, 2022

 

 

11

 

 

 

11

 

Additional paid-in capital

 

 

904,905

 

 

 

889,657

 

Accumulated other comprehensive loss

 

 

(2

)

 

 

(272

)

Accumulated deficit

 

 

(658,415

)

 

 

(533,426

)

Total stockholders’ equity

 

 

246,499

 

 

 

355,970

 

Total liabilities, preferred stock and stockholders’ equity

 

$

274,917

 

 

$

383,167

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

1


INVIVYD, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(UNaudited)

(In thousands, except share and per share amounts)

 

 

Three Months Ended September 30,

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

$

25,574

 

 

$

30,131

 

 

$

96,393

 

 

$

159,295

 

Acquired in-process research and development(2)

 

 

4,600

 

 

 

4,000

 

 

 

5,575

 

 

 

4,000

 

Selling, general and administrative

 

 

12,886

 

 

 

13,200

 

 

 

34,038

 

 

 

36,524

 

Total operating expenses

 

 

43,060

 

 

 

47,331

 

 

 

136,006

 

 

 

199,819

 

Loss from operations

 

 

(43,060

)

 

 

(47,331

)

 

 

(136,006

)

 

 

(199,819

)

Other income:

 

 

 

 

 

 

 

 

 

 

 

 

Other income

 

 

3,620

 

 

 

2,244

 

 

 

11,017

 

 

 

3,076

 

Total other income

 

 

3,620

 

 

 

2,244

 

 

 

11,017

 

 

 

3,076

 

Net loss

 

 

(39,440

)

 

 

(45,087

)

 

 

(124,989

)

 

 

(196,743

)

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on available-for-sale securities, net of tax

 

 

20

 

 

 

46

 

 

 

270

 

 

 

54

 

Comprehensive loss

 

$

(39,420

)

 

$

(45,041

)

 

$

(124,719

)

 

$

(196,689

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.36

)

 

$

(0.42

)

 

$

(1.14

)

 

$

(1.82

)

Weighted-average common shares outstanding, basic and diluted

 

 

109,754,812

 

 

 

108,420,674

 

 

 

109,333,684

 

 

 

108,154,397

 

(1)
Includes related-party amounts of $1,448 and $6,666 for the three and nine months ended September 30, 2023, respectively, and $1,742 and $6,027 for the three and nine months ended September 30, 2022, respectively (see Note 15).
(2)
Includes related-party amounts of $4,600 and $4,975 for the three and nine months ended September 30, 2023, respectively, and $4,000 for both the three and nine months ended September 30, 2022 (see Note 15).

The accompanying notes are an integral part of these condensed consolidated financial statements.

2


 

INVIVYD, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

(UNAUDITED)

(In thousands, except share amounts)

 

 

 

Common Stock

 

 

Treasury Stock

 

 

Additional
Paid-in

 

 

Accumulated Other Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at December 31, 2021

 

 

110,782,909

 

 

$

11

 

 

 

468,751

 

 

$

 

 

$

850,125

 

 

$

(8

)

 

$

(292,109

)

 

$

558,019

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Exercise of stock options

 

 

50,353

 

 

 

 

 

 

 

 

 

 

 

 

47

 

 

 

 

 

 

 

 

 

47

 

Repurchase of unvested restricted common stock

 

 

(1,158,089

)

 

 

 

 

 

1,158,089

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

(1,626,840

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,983

 

 

 

 

 

 

 

 

 

1,983

 

Unrealized gain on available-for-sale securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8

 

 

 

 

 

 

8

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(100,666

)

 

 

(100,666

)

Balances at March 31, 2022

 

 

109,675,173

 

 

$

11

 

 

 

 

 

$

 

 

$

852,156

 

 

$

 

 

$

(392,775

)

 

$

459,392

 

Exercise of stock options

 

 

98,000

 

 

 

 

 

 

 

 

 

 

 

 

76

 

 

 

 

 

 

 

 

 

76

 

Repurchase of unvested restricted common stock

 

 

(992,648

)

 

 

 

 

 

992,648

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,361

 

 

 

 

 

 

 

 

 

6,361

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(50,990

)

 

 

(50,990

)

Balances at June 30, 2022

 

 

108,780,525

 

 

$

11

 

 

 

992,648

 

 

$

 

 

$

858,593

 

 

$

 

 

$

(443,765

)

 

$

414,839

 

Exercise of stock options

 

 

125,000

 

 

 

 

 

 

 

 

 

 

 

 

97

 

 

 

 

 

 

 

 

 

97

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

(992,648

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock under the employee stock purchase plan

 

 

51,876

 

 

 

 

 

 

 

 

 

 

 

 

149

 

 

 

 

 

 

 

 

 

149

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7,399

 

 

 

 

 

 

 

 

 

7,399

 

Unrealized gain on available-for-sale securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

46

 

 

 

 

 

 

46

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(45,087

)

 

 

(45,087

)

Balances at September 30, 2022

 

 

108,957,401

 

 

$

11

 

 

 

 

 

$

 

 

$

866,238

 

 

$

46

 

 

$

(488,852

)

 

$

377,443

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Common Stock

 

 

Treasury Stock

 

 

Additional
Paid-in

 

 

Accumulated Other Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at December 31, 2022

 

 

109,044,046

 

 

$

11

 

 

 

 

 

$

 

 

$

889,657

 

 

$

(272

)

 

$

(533,426

)

 

$

355,970

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Exercise of stock options

 

 

423,203

 

 

 

 

 

 

 

 

 

 

 

 

459

 

 

 

 

 

 

 

 

 

459

 

Repurchase of unvested restricted common stock

 

 

(206,802

)

 

 

 

 

 

206,802

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

(206,802

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,400

 

 

 

 

 

 

 

 

 

5,400

 

Issuance of common stock under the employee stock purchase plan

 

 

55,779

 

 

 

 

 

 

 

 

 

 

 

 

83

 

 

 

 

 

 

 

 

 

83

 

Unrealized gain on available-for-sale securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

157

 

 

 

 

 

 

157

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(35,321

)

 

 

(35,321

)

Balances at March 31, 2023

 

 

109,316,226

 

 

$

11

 

 

 

 

 

$

 

 

$

895,600

 

 

$

(115

)

 

$

(568,747

)

 

$

326,749

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

Exercise of stock options

 

 

255,440

 

 

 

 

 

 

 

 

 

 

 

 

215

 

 

 

 

 

 

 

 

 

215

 

Repurchase of unvested restricted common stock

 

 

(46,600

)

 

 

 

 

 

46,600

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

(46,600

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,677

 

 

 

 

 

 

 

 

 

4,677

 

Issuance of common stock under the employee stock purchase plan

 

 

45,267

 

 

 

 

 

 

 

 

 

 

 

 

56

 

 

 

 

 

 

 

 

 

56

 

Unrealized gain on available-for-sale securities, net of tax

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

93

 

 

 

 

 

 

93

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(50,228

)

 

 

(50,228

)

Balances at June 30, 2023

 

 

109,570,333

 

 

$

11

 

 

 

 

 

$

 

 

$

900,549

 

 

$

(22

)

 

$

(618,975

)

 

$