SEC Filing - Invivyd

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10-Q

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


☐	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.

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

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.

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.

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	)	$	281,563