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 March 31, 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 May 4, 2023, the registrant had 109,481,666 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

23

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

34

Item 4.

Controls and Procedures

34

PART II.

OTHER INFORMATION

35

Item 1.

Legal Proceedings

35

Item 1A.

Risk Factors

35

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

35

Item 5.

Other Information

35

Item 6.

Exhibits

36

Signatures

37

 

i


PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

INVIVYD, INC.

Condensed Consolidated Balance Sheets

(UNaudited)

(In thousands, except share and per share amounts)

 

 

March 31,
2023

 

 

December 31,
2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

126,473

 

 

$

92,076

 

Marketable securities

 

 

206,955

 

 

 

279,915

 

Prepaid expenses and other current assets

 

 

11,195

 

 

 

4,926

 

Total current assets

 

 

344,623

 

 

 

376,917

 

Property and equipment, net

 

 

2,252

 

 

 

2,282

 

Operating lease right-of-use assets

 

 

3,398

 

 

 

3,777

 

Other non-current assets

 

 

291

 

 

 

191

 

Total assets

 

$

350,564

 

 

$

383,167

 

Liabilities, Preferred Stock and Stockholders’ Equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,913

 

 

$

1,517

 

Accrued expenses

 

 

14,501

 

 

 

21,911

 

Operating lease liabilities, current

 

 

1,585

 

 

 

1,559

 

Other current liabilities

 

 

58

 

 

 

44

 

Total current liabilities

 

 

22,057

 

 

 

25,031

 

Operating lease liabilities, non-current

 

 

1,758

 

 

 

2,165

 

Early-exercise liability

 

 

 

 

 

1

 

Total liabilities

 

 

23,815

 

 

 

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 March 31, 2023
           and December 31, 2022

 

 

 

 

 

 

        Common stock, $0.0001 par value; 1,000,000,000 shares authorized,
           
109,316,226 shares issued and outstanding at March 31, 2023;
           
109,044,046 shares issued and outstanding at December 31, 2022

 

 

11

 

 

 

11

 

Additional paid-in capital

 

 

895,600

 

 

 

889,657

 

Accumulated other comprehensive loss

 

 

(115

)

 

 

(272

)

Accumulated deficit

 

 

(568,747

)

 

 

(533,426

)

Total stockholders’ equity

 

 

326,749

 

 

 

355,970

 

Total liabilities, preferred stock and stockholders’ equity

 

$

350,564

 

 

$

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 March 31,

 

 

Three Months Ended March 31,

 

 

 

 

2023

 

 

2022

 

 

Operating expenses:

 

 

 

 

 

 

 

Research and development(1)

 

$

27,201

 

 

$

92,035

 

 

Acquired in-process research and development(2)

 

 

825

 

 

 

 

 

Selling, general and administrative

 

 

11,045

 

 

 

8,704

 

 

Total operating expenses

 

 

39,071

 

 

 

100,739

 

 

Loss from operations

 

 

(39,071

)

 

 

(100,739

)

 

Other income:

 

 

 

 

 

 

 

Other income

 

 

3,750

 

 

 

73

 

 

Total other income

 

 

3,750

 

 

 

73

 

 

Net loss

 

 

(35,321

)

 

 

(100,666

)

 

Other comprehensive income (loss)

 

 

 

 

 

 

 

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

 

 

157

 

 

 

8

 

 

Comprehensive loss

 

$

(35,164

)

 

$

(100,658

)

 

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

 

$

(0.32

)

 

$

(0.93

)

 

Weighted-average common shares outstanding, basic and diluted

 

 

108,785,519

 

 

 

107,869,570

 

 

(1)
Includes related-party amounts of $2,960 and $2,000 for the three months ended March 31, 2023 and 2022, respectively (see Note 15).
(2)
Includes related-party amounts of $375 and $0 for the three months ended March 31, 2023 and 2022, respectively (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

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

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

3


 

INVIVYD, INC.

Condensed Consolidated Statements of Cash Flows

(UNAUDITED)

(In thousands)

 

 

Three Months Ended March 31,

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(35,321

)

 

$

(100,666

)

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

 

 

 

 

 

 

Stock-based compensation expense

 

 

5,400

 

 

 

1,983

 

Net amortization of premiums and accretion of discounts on marketable securities

 

 

(2,543

)

 

 

194

 

Amortization of operating lease right-of-use assets

 

 

379

 

 

 

80

 

Depreciation expense

 

 

120

 

 

 

4

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(6,269

)

 

 

3,212

 

Other non-current assets

 

 

(100

)

 

 

3,060

 

Accounts payable

 

 

4,430

 

 

 

12,899

 

Accrued expenses

 

 

(6,909

)

 

 

20,260

 

Operating lease liabilities

 

 

(381

)

 

 

(69

)

Other current liabilities

 

 

13

 

 

 

 

Other non-current liabilities

 

 

 

 

 

(6

)

Net cash used in operating activities

 

 

(41,181

)

 

 

(59,049

)

Cash flows from investing activities:

 

 

 

 

 

 

Maturities of marketable securities

 

 

75,660

 

 

 

49,000

 

Purchases of property and equipment

 

 

(624

)

 

 

 

Net cash provided by investing activities

 

 

75,036

 

 

 

49,000

 

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from exercises of stock options

 

 

459

 

 

 

47

 

Proceeds from issuance of common stock under the employee stock purchase plan

 

 

83

 

 

 

 

Payments for repurchases of unvested restricted common stock

 

 

 

 

 

(2

)

Net cash provided by financing activities

 

 

542

 

 

 

45

 

Net increase (decrease) in cash and cash equivalents

 

 

34,397

 

 

 

(10,004

)

Cash and cash equivalents at beginning of period

 

 

92,076

 

 

 

542,224

 

Cash and cash equivalents at end of period

 

$

126,473

 

 

$

532,220

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

Operating lease right-of-use asset recognized upon adoption of ASC 842

 

$

 

 

$

1,728

 

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

4


 

INVIVYD, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

1. Nature of the Business and Basis of Presentation

Invivyd, Inc., together with its consolidated subsidiaries (the “Company”), is a biopharmaceutical company on a mission to rapidly and perpetually deliver antibody-based therapies that protect vulnerable people from the devastating consequences of circulating viral threats, beginning with SARS-CoV-2. The Company's technology works at the intersection of evolutionary virology, predictive modeling, and antibody engineering, and is designed to identify high-quality, long-lasting antibodies with the potential to resist viral escape. The Company is generating a robust pipeline of product candidates which could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications.

In March 2023, the Company announced dosing of the first participants in a Phase 1 clinical trial of VYD222, a monoclonal antibody (“mAb”) candidate for prevention of COVID-19. In May 2023, the Company completed the dosing of all participants in the Phase 1 clinical trial. The Phase 1 randomized, blinded, placebo-controlled, dose-ranging trial, which is being conducted in Australia, will evaluate the safety, pharmacokinetics, tolerability, and serum virus neutralizing activity of VYD222 in healthy adult volunteers. The dose-ranging trial will evaluate three different doses, each administered as a single IV push. All doses are designed to provide durability in the face of viral evolution and flexibility at the time of regulatory submission. Additionally, in April 2023, the Company announced that the U.S. Food and Drug Administration (“FDA”) cleared its Investigational New Drug (“IND”) application for VYD222.

VYD222 is the Company’s second mAb candidate to enter clinical testing. VYD222 has demonstrated in vitro neutralizing activity against prior and current SARS-CoV-2 variants of concern (“VoCs”), including Omicron sublineages up to and through XBB.1.5. VYD222 was engineered from adintrevimab, the Company’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 3 clinical trials for both the prevention and treatment of COVID-19.

Beyond VYD222, the Company plans to leverage its expanded laboratory capabilities and integrated discovery platform to produce additional candidates designed to optimize their ability to stay ahead of the evolving SARS-CoV-2 virus. In addition, the Company continues to engage with regulatory agencies with the goal of streamlining the development of novel antibodies to protect immunocompromised and other high-risk populations against the evolving SARS-CoV-2 virus. The Company is also developing its commercialization approach to determine how best to bring its product candidates, if authorized or approved, to these populations.

The Company was incorporated in the State of Delaware in June 2020. The Company operates as a hybrid company with employees working at its corporate headquarters in Waltham, Massachusetts and remotely. In June 2022, and subsequently amended in September 2022, the Company entered into a lease for dedicated laboratory and office space in Newton, Massachusetts for research and development purposes. In 2022, the Company expanded its research team in order to enable internal discovery and development of its mAb candidates, while continuing to leverage the Company’s existing partnership with Adimab, LLC (“Adimab”). The Company is focused on antibody discovery and use of Adimab’s platform technology while building its own internal capabilities. In addition, the Company performs research and development activities internally and engages third parties, including Adimab, to perform ongoing research and development and other services on its behalf.

The Company is subject to a number of risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, completing clinical trials, the ability to raise additional capital to fund operations, obtaining regulatory approval for product candidates, market acceptance of products, competition from substitute products, protection of proprietary intellectual property, compliance with government regulations, the impact of COVID-19, dependence on key personnel, the ability to attract and retain qualified employees, and reliance on third-party organizations for the discovery, manufacturing, clinical and commercial success of its product candidates.

The Company has not generated any revenue since inception. The Company’s product candidates require significant additional research and development efforts, including extensive clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and compliance-reporting capabilities. Even if the Company’s development efforts are successful, it is uncertain when, if ever, the Company will generate revenue from product sales, including government supply contracts.

The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities and commitments in the ordinary course of business. The Company has primarily funded its operations with proceeds from sales of convertible preferred stock and proceeds from the Company’s initial public offering (“IPO”). The Company has incurred losses and negative cash flows from operations since its inception, including a net loss of $35.3 million for the three months ended March 31, 2023. As of March 31, 2023, the Company had an accumulated deficit of $568.7 million. The Company expects to continue to generate operating losses for the foreseeable future. The Company expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the interim condensed consolidated financial statements.

5


 

The Company expects to seek additional funding through a combination of equity offerings, government or private-party funding or grants, debt financings, collaborations with other companies, strategic alliances and licensing arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into collaborations or other arrangements. The terms of any financing may adversely affect the holdings or rights of the Company’s stockholders.

If the Company is unable to obtain sufficient capital, the Company will be forced to delay, reduce or eliminate some or all of its research and development programs, product portfolio expansion, or future commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. Although management continues to pursue these plans, there is no assurance that the Company will be successful in obtaining sufficient funding on terms acceptable to the Company to fund continuing operations, if at all.

Impact of COVID-19 on the Company's Operations

The full impact of the COVID-19 pandemic and the disease continues to evolve and change as of the date of this Quarterly Report on Form 10-Q, and such impact will directly affect the potential commercial prospects of VYD222 and other product candidates for the prevention and treatment of COVID-19. The severity of the COVID-19 pandemic, the evolution of the disease and the continued emergence of VoCs, and the availability, administration and acceptance of vaccines, mAbs, antiviral agents and other therapeutic modalities will affect the design and enrollment of the Company’s clinical trials, the potential regulatory authorization or approval of the Company’s product candidates and the commercialization of the Company’s product candidates, if authorized or approved.

Similarly, it is not possible to determine the scale and rate of economic recovery from the pandemic, supply chain disruptions, and labor availability and costs, or the impact of other indirect factors that may be attributable to the pandemic. The ultimate extent of the impact of the COVID-19 pandemic on the Company’s business, financial condition, operations and product development timelines and plans remains uncertain and will depend on future developments, including the duration and spread of outbreaks and the continued emergence of variants, its impact on the Company’s clinical trial design and enrollment, trial sites, clinical research organizations (“CROs”), contract development and manufacturing organizations (“CDMOs”), and other third parties with which the Company does business, as well as its impact on regulatory authorities and the Company’s key scientific and management personnel. To date, the Company has experienced some delays and disruptions in its development activities as a result of the COVID-19 pandemic. Some of the Company’s CROs, CDMOs and other service providers also continue to be impacted. The Company will continue to monitor developments as it addresses the disruptions, delays and uncertainties relating to the COVID-19 pandemic. If the financial markets and/or the overall economy are impacted for an extended period, the Company’s results and operations may be materially adversely affected and may affect the Company’s ability to raise capital.

Basis of Presentation

The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”).

The accompanying condensed consolidated financial statements include the accounts of Invivyd, Inc. and its wholly owned subsidiaries, Invivyd Security Corporation, Invivyd Switzerland GmbH, and Invivyd Netherlands B.V. All intercompany accounts and transactions have been eliminated in consolidation. The Company views its operations and manages its business in one operating segment, which is the business of discovering, developing and commercializing differentiated products for the prevention and treatment of infectious diseases.

2. Summary of Significant Accounting Policies

As of March 31, 2023, the Company’s significant accounting policies and estimates, which are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, as filed with the U.S. Securities and Exchange Commission (“SEC”) on March 23, 2023 (the “2022 Form 10-K”) have not changed, except as discussed below.

On January 1, 2023, the Company adopted Accounting Standards Update No. 2016-13 (“ASU 2016-13”), Financial Instruments-Credit Losses: Measurement of Credit Losses on Financial Instruments. ASU 2016-13 requires measurement and recognition of expected credit losses for financial assets. In April 2019, the FASB issued clarification to ASU 2016-13 within ASU 2019-04, Codification Improvements to Topic 326, Financial Instruments-Credit Losses, Topic 815, Derivatives and Hedging, and Topic 825, Financial Instruments, or ASU 2016-13. The guidance is effective for fiscal years beginning after December 15, 2022. The adoption of the standard was immaterial to the accompanying condensed consolidated financial statements and related disclosures.

Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of March 31, 2023, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2023 and 2022, the condensed consolidated statements of cash flows for the three months ended March 31, 2023 and 2022 and the condensed consolidated statements of stockholders’ equity (deficit) for the three months ended March 31, 2023 and 2022 are unaudited.

6


 

The accompanying unaudited condensed consolidated financial statements as of March 31, 2023 and for the three months ended March 31, 2023 and 2022 have been prepared by the Company pursuant to the rules and regulations of the SEC for interim financial statements. The accompanying condensed consolidated balance sheet as of December 31, 2022 was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. These interim condensed consolidated financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements, and the notes thereto, as of and for the year ended December 31, 2022, which are included in the Company’s 2022 Form 10-K.

In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of March 31, 2023 and December 31, 2022, the condensed consolidated results of operations for the three months ended March 31, 2023 and 2022, the condensed consolidated cash flows for the three months ended March 31, 2023 and 2022 and changes in stockholders’ equity (deficit) for the three months ended March 31, 2023 and 2022 have been made. The Company’s condensed consolidated results of operations for the three months ended March 31, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

Use of Estimates

The preparation of the Company’s condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these condensed consolidated financial statements include, but are not limited to, research and development expenses and related prepaid or accrued costs and stock-based compensation expense. The Company bases its estimates on historical experience, known trends and other market-specific or relevant factors it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results may differ materially from those estimates or assumptions.

The Company is monitoring the potential impact of the COVID-19 pandemic on its business and condensed consolidated financial statements. The Company is not aware of any specific event or circumstance that would require any update to its estimates or judgments reflected in these condensed consolidated financial statements or a revision of the carrying value of its assets or liabilities as of the issuance date of these condensed consolidated financial statements. These estimates may change as new events occur and additional information is obtained.

Recently Issued and Adopted Accounting Pronouncements

The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and will remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of its IPO. However, if certain events occur prior to the end of such five-year period, including if it becomes a “large accelerated filer,” its annual gross revenues exceeds $1.235 billion or it issues more than $1.0 billion of non-convertible debt in the previous three-year period, it will cease to be an emerging growth company prior to the end of such five-year period. For so long as the Company remains an emerging growth company, it is permitted and intends to rely on exemptions from certain disclosure requirements that are applicable to other public companies that are not emerging growth companies. For example, the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. This allows an emerging growth company to delay the adoption of these accounting standards until they would otherwise apply to private companies.

There have been no new accounting pronouncements or changes to accounting pronouncements that could be expected to materially impact the Company’s unaudited condensed consolidated financial statements during the three months ended March 31, 2023, as compared to the recent accounting pronouncements described in Note 2 of the Company’s condensed consolidated financial statements included in its 2022 Form 10-K.

3. Marketable Securities

Marketable securities held by the Company are classified as available-for-sale debt securities pursuant to ASC 320, Investments – Debt and Equity Securities, and carried at fair value in the accompanying condensed consolidated balance sheet on a settlement date basis.

The following tables summarize the gross unrealized gains, unrealized losses and credit losses of the Company’s marketable securities as of March 31, 2023 and December 31, 2022 (in thousands):

March 31, 2023

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Credit Losses

 

 

Fair Value

 

U.S. Treasury securities

 

$

90,991

 

 

$

4

 

 

$

(60

)

 

$

 

 

$

90,935

 

Federal agency securities

 

 

116,079

 

 

 

17

 

 

 

(76

)

 

 

 

 

 

116,020

 

Total financial assets

 

$

207,070

 

 

$

21

 

 

$

(136

)

 

$

 

 

$

206,955

 

 

7


 

December 31, 2022

 

Amortized Cost

 

 

Unrealized Gains

 

 

Unrealized Losses

 

 

Credit Losses

 

 

Fair Value

 

U.S. Treasury securities

 

$

107,973

 

 

$

13

 

 

$

(115

)

 

$

 

 

$

107,871

 

Federal agency securities

 

 

172,214

 

 

 

39

 

 

 

(209

)

 

 

 

 

 

172,044

 

Total financial assets

 

$

280,187

 

 

$

52

 

 

$

(324

)

 

$

 

 

$

279,915

 

The Company did not record any charges for credit-related impairments for its available-for-sale securities during the three months ended March 31, 2023.

No available-for-sale marketable securities held as of March 31, 2023 or December 31, 2022 had remaining maturities greater than twelve months.

4. Fair Value Measurements

Fair Value Measurements

Certain assets of the Company are carried at fair value under U.S. GAAP. Fair value is defined as the exchange price that would be received for an asset or an exit price that would be paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:

 

 

Level 1 — Quoted prices in active markets for identical assets or liabilities.

 

 

 

Level 2 — Observable inputs (other than Level 1 quoted prices), such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.

 

 

 

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.

The Company’s cash equivalents and marketable securities are carried at fair value, determined according to the fair value hierarchy described above. The carrying values of the Company’s accounts payable and accrued expenses approximate their fair values due to the short-term nature of these liabilities.

The following ta