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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, 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: 001-40703

 

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

 

Adagio Therapeutics, Inc.

(Former name, former address and former fiscal year, if changed since last report)

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 3, 2022, the registrant had 108,982,401 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 Statement of Convertible Preferred Stock and Stockholders’ Equity (Deficit)

3

 

Condensed Consolidated Statements of Cash Flows

5

 

Notes to Unaudited Condensed Consolidated Financial Statements

6

Item 2.

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

24

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

38

Item 4.

Controls and Procedures

38

PART II.

OTHER INFORMATION

39

Item 1.

Legal Proceedings

39

Item 1A.

Risk Factors

39

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

92

Item 6.

Exhibits

93

Signatures

94

 

i


 

SUMMARY OF RISK FACTORS

 

The following summarizes the principal factors that make an investment in us speculative or risky, all of which are more fully described in the Risk Factors section below. This summary should be read in conjunction with the Risk Factors section and should not be relied upon as an exhaustive summary of the material risks facing our business.

 

Risks Related to our Financial Position and Capital Needs

We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or maintain profitability.
We have a limited operating history and no history of commercializing products, which may make it difficult for an investor to evaluate the success of our business to date and to assess our future viability.
We will need substantial additional funding to meet our financial obligations and to pursue our business objectives. If we are unable to raise capital when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

 

Risks Related to the Development of our Product Candidates

We continue to monitor the evolution of SARS-CoV-2 and the in vitro activity of adintrevimab against predominant variants in the United States to identify a potential opportunity for an EUA request in the event of a susceptible variant. We cannot be certain that adintrevimab will neutralize future variants and that we will submit an EUA for adintrevimab or whether an EUA will be granted if we do submit such request.
All of our product candidates are currently in clinical and preclinical development. If we are unable to successfully develop, receive regulatory approval or EUA for and commercialize our product candidates for the indications we seek, or successfully develop any other product candidates, or experience significant delays in doing so, our business will be harmed.
Because our product candidates represent novel approaches to the prevention and treatment of disease, there are many uncertainties regarding the development, market acceptance, third-party reimbursement coverage and commercial potential of our product candidates.
Newly emerging and future SARS-CoV-2 variants could reduce the activity and effectiveness of antibodies targeting the receptor binding domain region as a potential prevention of or treatment for symptomatic COVID-19. We may not be successful in identifying new antibodies that are suitable either as monotherapy or as combination therapy to mitigate the risk of reduced activity against future SARS-CoV-2 variants.
Our integrated discovery platform approach may not produce durable, broadly neutralizing, or effective antibodies in the timeframe necessary to address a changing virus.
There can be no assurance that the Public Health Emergency will continue to be in place for an extended period of time and that the product candidates we are developing for COVID-19 could be granted an EUA by the FDA or similar authorization by regulatory authorities outside of the United States if we decide to apply for such an authorization. If we do not apply for such an authorization or, if we do apply and no authorization is granted or, once granted, it is terminated, we will be unable to sell our product candidates in the near future and instead, will be required to pursue solely the traditional regulatory approval processes of the FDA and comparable foreign authorities, which are lengthy, time consuming and inherently unpredictable. If we are not able to obtain required regulatory approval for our product candidates, our business will be substantially harmed.
Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. Our product candidates may not have favorable results in later clinical trials, if any, or receive regulatory approval.
Lack of awareness or negative public opinion of monoclonal antibody therapies and increased regulatory scrutiny of monoclonal antibody therapies to prevent or treat COVID-19 may adversely impact the development or commercial success of our product candidates.
We may experience delays or difficulties in the enrollment and/or retention of patients in clinical trials, or we may pause, delay or terminate enrollment in our clinical trials, which could in turn delay or prevent our receipt of necessary regulatory approvals.
We may not be successful in our efforts to build a pipeline of additional product candidates through internal efforts or through partnerships for discovery of novel antibody product candidates.
Our business and operations may be adversely affected by the evolving and ongoing COVID-19 global pandemic.

ii


 

 

Risks Related to the Manufacturing of our Product Candidates

Monoclonal antibody therapies are complex and difficult to manufacture, and we rely on contract manufacturers for access to capacity. We could experience manufacturing problems, may be unable to access desired manufacturing capacity within desired timeframes, or may be unable to access raw materials due to global supply chain shortages or otherwise, that result in delays in the development, supply, or commercialization of our product candidates or otherwise harm our business.

 

Risks Related to the Commercialization of Our Product Candidates

The affected populations for our product candidates may be smaller than we or third parties currently project, which may affect our ability to enroll our clinical trials as well as the addressable markets for our product candidates.
Our monoclonal antibody product candidates may face significant competition from vaccines, antiviral agents and other therapeutics for COVID-19 that are currently available or in development.

 

Risks Related to Our Intellectual Property

If we are unable to obtain, maintain and enforce patent protection for our product candidates, or if the scope of the patent protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours and our ability to successfully develop and commercialize our product candidates may be adversely affected.
Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain.

 

Risks Related to Ownership of Our Common Stock and Our Status as a Public Company

We previously identified a material weakness in our internal control over financial reporting, which has since been remediated. We may identify future material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we fail to establish and maintain adequate internal control over financial reporting, we may not be able to produce timely and accurate financial statements, and we may conclude that our internal control over financial reporting is not effective, which may adversely affect our business.

iii


 

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,
2022

 

 

December 31,
2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

278,152

 

 

$

542,224

 

Marketable securities

 

 

140,517

 

 

 

49,194

 

Prepaid expenses and other current assets

 

 

2,927

 

 

 

25,293

 

Total current assets

 

 

421,596

 

 

 

616,711

 

Property and equipment, net

 

 

1,429

 

 

 

83

 

Operating lease right-of-use assets

 

 

1,486

 

 

 

 

Other non-current assets

 

 

236

 

 

 

3,297

 

Total assets

 

$

424,747

 

 

$

620,091

 

Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

16,770

 

 

$

5,783

 

Accrued expenses

 

 

28,974

 

 

 

56,277

 

Operating lease liability, current

 

 

329

 

 

 

 

Other current liabilities

 

 

53

 

 

 

 

Total current liabilities

 

 

46,126

 

 

 

62,060

 

Early-exercise liability

 

 

1

 

 

6

 

Operating lease liability, non-current

 

 

1,177

 

 

 

 

Other non-current liability

 

 

 

 

 

6

 

Total liabilities

 

 

47,304

 

 

 

62,072

 

Commitments and contingencies (Note 8)

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

        Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares
           authorized and
no shares issued and outstanding at September 30, 2022
           and December 31, 2021

 

 

 

 

 

 

        Common stock, $0.0001 par value; 1,000,000,000 shares authorized,
           
108,957,401 shares issued and outstanding at September 30, 2022;
           
1,000,000,000 shares authorized, 111,251,660 shares issued and
           
110,782,909 shares outstanding at December 31, 2021

 

 

11

 

 

 

11

 

        Treasury stock, at cost; 0 shares and 468,751 shares at
          September 30, 2022 and December 31, 2021, respectively

 

 

 

 

 

 

Additional paid-in capital

 

 

866,238

 

 

 

850,125

 

Accumulated other comprehensive income (loss)

 

 

46

 

 

 

(8

)

Accumulated deficit

 

 

(488,852

)

 

 

(292,109

)

Total stockholders’ equity (deficit)

 

 

377,443

 

 

 

558,019

 

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

 

$

424,747

 

 

$

620,091

 

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,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development(1)

 

$

30,131

 

 

$

45,366

 

 

$

159,295

 

 

$

114,465

 

Acquired in-process research and development(2)

 

 

4,000

 

 

 

4,000

 

 

 

4,000

 

 

 

7,500

 

Selling, general and administrative

 

 

13,200

 

 

 

11,052

 

 

 

36,524

 

 

 

21,853

 

Total operating expenses

 

 

47,331

 

 

 

60,418

 

 

 

199,819

 

 

 

143,818

 

Loss from operations

 

 

(47,331

)

 

 

(60,418

)

 

 

(199,819

)

 

 

(143,818

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

 

2,244

 

 

 

43

 

 

 

3,076

 

 

 

70

 

Total other income (expense), net

 

 

2,244

 

 

 

43

 

 

 

3,076

 

 

 

70

 

Net loss

 

 

(45,087

)

 

 

(60,375

)

 

 

(196,743

)

 

 

(143,748

)

Other comprehensive income (loss)

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

46

 

 

 

3

 

 

 

54

 

 

 

3

 

Comprehensive loss

 

$

(45,041

)

 

$

(60,372

)

 

$

(196,689

)

 

$

(143,745

)

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

 

$

(0.42

)

 

$

(0.98

)

 

$

(1.82

)

 

$

(7.06

)

Weighted-average common shares outstanding, basic and diluted

 

 

108,420,674

 

 

 

61,297,086

 

 

 

108,154,397

 

 

 

20,346,771

 

(1)
Includes related-party amounts of $1,742 and $6,027 for the three and nine months ended September 30, 2022, respectively, and $1,826 and $2,261 for the three and nine months ended September 30, 2021, respectively (see Note 15).
(2)
Includes related-party amounts of $4,000 for both the three and nine months ended September 30, 2022, and $4,000 and $7,500 for the three and nine months ended September 30, 2021, respectively (see Note 15).

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

2


 

INVIVYD, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE

PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)

(UNAUDITED)

(In thousands, except share amounts)

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Treasury Stock

 

 

Additional
Paid-in

 

 

Accumulated Other Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at December 31, 2020

 

 

12,647,934

 

 

$

169,548

 

 

 

 

5,593,240

 

 

$

1

 

 

 

22,600,000

 

 

$

(85

)

 

$

154

 

 

$

 

 

$

(65,319

)

 

$

(65,249

)

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

587

 

 

 

 

 

 

 

 

 

587

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,700

)

 

 

(38,700

)

Balances at March 31, 2021

 

 

12,647,934

 

 

$

169,548

 

 

 

 

5,593,240

 

 

$

1

 

 

 

22,600,000

 

 

$

(85

)

 

$

741

 

 

$

 

 

$

(104,019

)

 

$

(103,362

)

Issuance of Series C convertible preferred stock, net of issuance costs of $337

 

 

4,296,550

 

 

 

335,163

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock

 

 

 

 

 

 

 

 

 

6,000

 

 

 

 

 

 

 

 

 

 

 

 

66

 

 

 

 

 

 

 

 

 

66

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,342

 

 

 

 

 

 

 

 

 

3,342

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

3

 

Retirement of treasury stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(22,600,000

)

 

 

85

 

 

 

(85

)

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(44,673

)

 

 

(44,673

)

Balances at June 30, 2021

 

 

16,944,484

 

 

$

504,711

 

 

 

 

5,599,240

 

 

$

1

 

 

$

 

 

$

 

 

$

4,067

 

 

$

 

 

$

(148,692

)

 

$

(144,624

)

Issuance of common stock upon completion of initial public offering, net of commissions, underwriting discounts and offering costs

 

 

 

 

 

 

 

 

 

20,930,000

 

 

 

2

 

 

 

 

 

 

 

 

 

327,518

 

 

 

 

 

 

 

 

 

327,520

 

Conversion of convertible preferred stock to common stock

 

 

(16,944,484

)

 

 

(504,711

)

 

 

 

84,722,420

 

 

 

2

 

 

 

 

 

 

 

 

 

504,707

 

 

 

 

 

 

 

 

 

504,709

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,979

 

 

 

 

 

 

 

 

 

5,979

 

Vesting of restricted common stock from early-exercised options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

 

 

 

 

 

 

 

 

1

 

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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

 

 

 

 

 

3

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(60,375.0

)

 

 

(60,375

)

Balances at September 30, 2021

 

 

 

 

$

 

 

 

 

111,251,660

 

 

$

5

 

 

 

 

 

$

 

 

$

842,272

 

 

$

3

 

 

$

(209,067

)

 

$

633,213

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Convertible Preferred Stock

 

 

 

Common Stock

 

 

Treasury Stock

 

 

Additional
Paid-in

 

 

Accumulated Other Comprehensive

 

 

Accumulated

 

 

Total
Stockholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balances at December 31, 2021

 

 

 

 

$

 

 

 

 

110,782,909

 

 

$

11

 

 

 

468,751

 

 

$

 

 

$

850,125

 

 

$