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INDEX TO CONSOLI DATED FINANCIAL STATEMENTS Page Report of Independent Registered Public Accounting Firm (PCAOB ID 238) F- 2 Consolidated Balance Sheets F- 3 Consolidated Statements of Operations and Comprehensive Loss F

Key Takeaway: The report from PricewaterhouseCoopers outlines Invivyd, Inc.'s consolidated financial statements for the years ending December 31, 2022, and 2021. It highlights ongoing financial struggles, including recurring operational losses and substantial doubt regarding the company's ability to continue as a going concern. The report indicates that the company will need to secure additional funding to support its future operations.

Market Sentiment Analysis

CONCERNS & RISKS

  • The company has incurred recurring losses from operations since inception.
  • Substantial doubt has been raised about the company's ability to continue as a going concern.
  • The company will require additional funding to finance its future operations.

Full Press Release Details

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 238) F- 2
Consolidated Balance Sheets F- 3
Consolidated Statements of Operations and Comprehensive Loss F- 4
Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit) F- 5
Consolidated Statements of Cash Flows F- 7
Notes to Consolidated Financial Statements F- 8
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Invivyd, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Invivyd, Inc. and its subsidiaries (the "Company") as of December 31, 2022 and 2021, and the related consolidated statements of operations and comprehensive loss, of convertible preferred stock and stockholders' equity (deficit) and of cash flows for the years then ended, including the related notes (collectively referred to as the "consolidated financial statements"). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2022 and 2021, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.
Substantial Doubt about the Company's Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the consolidated financial statements, the Company has incurred recurring losses from operations since inception and will require additional funding to finance its future operations. These conditions raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
These consolidated financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
March 23, 2023, except with respect to the matters that raise substantial doubt about the Company's ability to continue as a going concern discussed in Note 1, as to which the date is February 9, 2024
We have served as the Company's auditor since 2021.
Consolidated Balance Sheets
(In thousands, except share and per share amounts)
December 31,
2022 2021
Assets
Current assets:
Cash and cash equivalents $ 92,076 $ 542,224
Marketable securities 279,915 49,194
Prepaid expenses and other current assets 4,926 25,293
Total current assets 376,917 616,711
Property and equipment, net 2,282 83
Operating lease right-of-use assets 3,777 -
Other non-current assets 191 3,297
Total assets $ 383,167 $ 620,091
Liabilities, Convertible Preferred Stock and Stockholders' Equity (Deficit)
Current liabilities:
Accounts payable $ 1,517 $ 5,783
Accrued expenses 21,911 56,277
Operating lease liabilities, current 1,559 -
Other current liabilities 44 -
Total current liabilities 25,031 62,060
Operating lease liabilities, non-current 2,165 -
Early-exercise liability 1 6
Other non-current liability - 6
Total liabilities 27,197 62,072
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 December 31, 2022 and December 31, 2021 - -
Common stock, $ 0.0001 par value; 1,000,000,000 shares authorized, 109,044,046 shares issued and outstanding at December 31, 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 December 31, 2022 and December 31, 2021, respectively - -
Additional paid-in capital 889,657 850,125
Accumulated other comprehensive income (loss) ( 272 ) ( 8 )
Accumulated deficit ( 533,426 ) ( 292,109 )
Total stockholders' equity 355,970 558,019
Total liabilities, convertible preferred stock and stockholders' equity $ 383,167 $ 620,091
The accompanying notes are an integral part of these consolidated financial statements.
Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share amounts)
Year Ended December 31,
2022 2021
Operating expenses:
Research and development (1) $ 179,214 $ 182,891
Acquired in-process research and development (2) 4,400 7,500
Selling, general and administrative 47,044 36,517
Warrant expense (3) 17,373 -
Total operating expenses 248,031 226,908
Loss from operations ( 248,031 ) ( 226,908 )
Other income (expense):
Other income (expense), net 6,714 118
Total other income (expense), net 6,714 118
Net loss ( 241,317 ) ( 226,790 )
Other comprehensive loss:
Unrealized loss on available-for-sale securities, net of tax ( 264 ) ( 8 )
Comprehensive loss $ ( 241,581 ) $ ( 226,798 )
Net loss per share attributable to common stockholders, basic and diluted $ ( 2.23 ) $ ( 5.32 )
Weighted-average common shares outstanding, basic and diluted 108,268,289 42,621,265
(1)Includes related-party amounts of $8,154 and $4,150 for the years ended December 31, 2022 and 2021, respectively (see Notes 7 and 8).
(2)Includes related-party amounts of $4,400 and $7,500 for the years ended December 31, 2022 and 2021, respectively (see Note 7).
(3)Includes related-party amounts of $17,373 and $0 for the years ended December 31, 2022 and 2021, respectively (see Note 8).
The accompanying notes are an integral part of these consolidated financial statements.
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)
(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 Loss Deficit Equity (Deficit)
Balances at December 31, 2021 - - 110,782,909 11 468,751 - 850,125 ( 8 ) ( 292,109 ) 558,019
Issuance of warrants for common stock - - - - - - 17,373 - - 17,373
Exercise of stock options - - 298,353 - - - 241 - - 241
Repurchase of unvested restricted common stock - - ( 2,150,737 ) - 2,150,737 - - - - -
Retirement of treasury stock - - - - ( 2,619,488 ) - - - - -
Stock-based compensation expense - - - - - - 21,648 - - 21,648
Issuance of common stock under the employee stock purchase plan - - 113,521 - - - 269 - - 269
Vesting of restricted common stock from early- exercised options - - - - - - 1 - - 1
Unrealized loss on available-for-sale securities, net of tax - - - - - - - ( 264 ) - ( 264 )
Net loss - - - - - - - - ( 241,317 ) ( 241,317 )
Balances at December 31, 2022 - $ - 109,044,046 $ 11 - $ - $ 889,657 $ ( 272 ) $ ( 533,426 ) $ 355,970
The accompanying notes are an integral part of these consolidated financial statements.
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT)
(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 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 )
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
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 8 - - 504,703 - - 504,711
Retirement of treasury stock - - - - ( 22,600,000 ) $ 85 ( 85 ) - - -
Vesting of restricted common stock from early- exercised options - - - - - - 5 - - 5
Repurchase of unvested restricted common stock - - ( 468,751 ) - 468,751 - - - - -
Stock-based compensation expense - - - - - - 17,764 - - 17,764
Unrealized loss on available-for-sale securities, net of tax - - - - - - - ( 8 ) - ( 8 )
Net loss - - - - - - - - ( 226,790 ) ( 226,790 )
Balances at December 31, 2021 - $ - 110,782,909 $ 11 468,751 $ - $ 850,125 $ ( 8 ) $ ( 292,109 ) $ 558,019
The accompanying notes are an integral part of these consolidated financial statements.
Consolidated Statements of Cash Flows
Year Ended December 31,
2022 2021
Cash flows from operating activities:
Net loss $ ( 241,317 ) $ ( 226,790 )
Adjustments to reconcile net loss to net cash used in operating activities: -
Stock-based compensation expense 21,648 17,764
Warrant expense 17,373 -
Net amortization of premiums and accretion of discounts on marketable securities ( 2,023 ) 1,430
Amortization of operating lease right-of-use assets 421 -
Non-cash payments - 66
Depreciation expense 41 1
Changes in operating assets and liabilities:
Prepaid expenses and other current assets 20,367 ( 22,899 )
Other non-current assets 3,106 ( 3,297 )
Accounts payable ( 4,300 ) ( 2,370 )
Accrued expenses ( 34,867 ) 51,358
Operating lease liabilities ( 475 ) -
Other current liabilities 44 -
Other non-current liabilities ( 5 ) 1
Net cash used in operating activities ( 219,987 ) ( 184,736 )
Cash flows from investing activities:
Purchases of marketable securities ( 297,962 ) ( 188,627 )
Maturities of marketable securities 69,000 138,000
Purchases of property and equipment ( 1,705 ) ( 84 )
Net cash used in investing activities ( 230,667 ) ( 50,711 )
Cash flows from financing activities:
Proceeds from issuance of convertible preferred stock, net of issuance costs - 335,163
Proceeds from issuance of common stock, net of commissions and underwriting discounts - 330,905
Payments of initial public offering costs - ( 3,385 )
Proceeds from exercises of stock options 241 -
Proceeds from issuance of common stock under the employee stock purchase plan 269 -
Payments for repurchases of unvested restricted common stock ( 4 ) -
Net cash provided by financing activities 506 662,683
Net (decrease) increase in cash and cash equivalents ( 450,148 ) 427,236
Cash and cash equivalents at beginning of period 542,224 114,988
Cash and cash equivalents at end of period $ 92,076 $ 542,224
Supplemental disclosure of cash flow information:
Operating lease right-of-use asset recognized upon adoption of ASC 842 $ 1,728 $ -
Operating lease right-of-use asset recognized under ASC 842 $ 2,470 $ -
Supplemental disclosure of non-cash investing activities:
Purchases of property and equipment in accounts payable and accrued expenses $ 535 $ -
The accompanying notes are an integral part of these consolidated financial statements.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Nature of the Business and Basis of Presentation
Invivyd, Inc., (formerly Adagio Therapeutics, 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 ("COVID-19"). 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 a high barrier to 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 the election of VYD222 to advance into the clinic as a monoclonal antibody ("mAb") therapeutic option for COVID-19 with a focus on serving vulnerable populations. The Company aims to leverage evolving COVID-19 regulatory paradigms and maximize efficiency to deliver this much-needed product for immunocompromised individuals and other vulnerable populations.
VYD222 is one of two mAb components of NVD200, a combination mAb product candidate that the Company previously selected for clinical advancement prior to evolution in the current global COVID-19 regulatory paradigm. The Company is prioritizing the clinical development of VYD222 instead of NVD200 with the aim of providing patients with a therapeutic option for COVID-19 as quickly and efficiently as possible. 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 continues to leverage its expanded lab capabilities and integrated discovery platform to produce additional candidates that will be optimized to stay ahead of the evolving SARS-CoV-2 virus. In addition, the Company continues to work with regulatory agencies to streamline the development and commercialization plans for novel antibodies to protect immunocompromised and other high-risk populations against the evolving SARS-CoV-2 virus.
The Company was incorporated in the State of Delaware in June 2020. The Company operates as a virtual company and maintains a corporate headquarters for general and administrative purposes only. In June 2022, and subsequently amended in September 2022, the Company entered into a lease for dedicated laboratory and office space in Newton, MA for research and development purposes. The Company performs research and development activities internally and engages third parties, including Adimab, LLC ("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.
In July 2021, the Company effected a five-for-one stock split of its issued and outstanding shares of common stock and a proportional adjustment to the existing conversion ratios of each series of the Company's preferred stock (see Note 10). Accordingly, all share and per share amounts for all periods presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted retroactively, where applicable, to reflect this stock split and adjustment of the preferred stock conversion ratios.
In August 2021, the Company completed its initial public offering ("IPO") pursuant to which it issued and sold 20,930,000 shares of its common stock, including 2,730,000 shares pursuant to the full exercise of the underwriters' option to purchase additional shares. The aggregate net proceeds received by the Company from the IPO were approximately $327.5 million, after deducting underwriting discounts and commissions and offering expenses payable by the Company. Upon the closing of the IPO, all shares of the Company's convertible preferred stock then outstanding converted into 84,722,420 shares of common stock (see Note 11).
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.
Substantial Doubt about Ability to Continue as a Going Concern
The accompanying 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 of common stock. The Company has incurred losses and negative cash flows from operations since its inception, including a net loss of $241.3 million for the year ended December 31, 2022. As of December 31, 2022, the Company had an accumulated deficit of $533.4 million. The Company expects to continue to generate operating losses for the foreseeable future.
Subsequent to the original issuance of the consolidated financial statements for the year ended December 31, 2022, the Company continued to spend according to its operating plan in 2023. Based on current operating plans and excluding any contribution from revenues or external financing, the Company believes that its existing cash and cash equivalents will be sufficient to fund its operating expenses and capital expenditure requirements into the fourth quarter of 2024. As such, excluding any contribution from revenues or external financing, the Company will not have sufficient cash and cash equivalents to fund its operating expenses and capital requirements beyond one year from the reissuance of these consolidated financial statements on February 9, 2024, and therefore, the Company has concluded that there is substantial doubt about its ability to continue as a going concern.
The Company will require additional funding through a combination of contribution from revenues, equity offerings, government or private-party grants, debt financings or other capital sources, including collaborations with other companies, strategic alliances and licensing arrangements to finance its future operations. 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 Our Operations
The full impact of the COVID-19 pandemic and the disease continues to evolve and change as of the date of this Annual Report on Form 10-K, 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 variants of concern ("VoCs"), the availability, administration and acceptance of vaccines, monoclonal antibodies, antiviral agents and other therapeutic modalities, vaccine mandates by employers and/or local or national governments, and the potential development of "herd immunity" by the global population 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 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, contract 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 accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB").
The accompanying 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
The preparation of the Company's consolidated financial statements in conformity with 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 consolidated financial statements, and the reported amounts of expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, research and development expenses and related prepaid or accrued costs, stock-based compensation expense and warrant 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 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 consolidated financial statements or a revision of the carrying value of its assets or liabilities as of the issuance date of these consolidated financial statements. These estimates may change as new events occur and additional information is obtained.
Concentrations of Credit Risk, Significant Suppliers and License Rights
Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents and marketable securities. The Company invests its excess cash in money market funds and marketable securities that are subject to minimal credit and market risks. The Company maintains its cash, cash equivalents and marketable securities at two accredited financial institutions that it believes are creditworthy. From time to time, these deposits may exceed federally insured limits. The Company has not experienced any losses historically in these accounts. Accordingly, the Company does not believe it is exposed to unusual credit risk related to its cash, cash equivalents and marketable securities beyond the normal credit risk associated with commercial banking relationships.
The Company is dependent on third-party organizations to manufacture and process its product candidates for its development programs. In particular, the Company relies on a single third-party contract manufacturer to produce and process its product candidates and to manufacture supply of its product candidates for preclinical and clinical activities (see Note 9). The Company also currently relies on this same third-party contract manufacturer for any anticipated requirements of commercial supply, including both drug substance and drug product. The Company expects to continue to be dependent on a small number of manufacturers to supply it with its requirements for all products. The Company's research and development programs, including any associated potential commercialization efforts, could be adversely affected by a significant interruption in the supply of the necessary materials.
The Company is dependent on a limited number of third parties that provide license rights used by the Company in the development and potential commercialization of its product candidates and programs. Through December 31, 2022, the Company's research and development programs primarily relate to rights conveyed by Adimab (see Note 7). The Company could experience delays in the development and potential commercialization of its product candidates and programs if the Adimab agreements or any other license agreement utilized in the Company's research and development activities is terminated, if the Company fails to meet the obligations required under its arrangements, or if the Company is unable to successfully secure new strategic alliances or licensing agreements.
The Company considers all highly liquid investments with original maturities of three months or less at the acquisition date to be cash equivalents.
Marketable Securities
Marketable securities represent holdings of available-for-sale marketable debt securities in accordance with the Company's investment policy. The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. The Company classified all of its marketable securities at December 31, 2022 as "available-for-sale" pursuant to ASC320, Investments - Debt and Equity Securities. Investments not classified as cash equivalents are presented as either short-term or long-term investments based on both their maturities as well as the time period the Company intends to hold such securities. Available-for-sale securities are maintained by an investment manager and consist of U.S. Treasury securities and federal agency securities. Available-for-sale securities are carried at fair value with the unrealized gains and losses included in other comprehensive income (loss) as a component of stockholders' equity (deficit) until realized. Any premium or discount arising at purchase is amortized or accreted to interest expense or income over the life of the instrument. Realized gains and losses are determined using the specific identification method and are included in other income (expense). There were no material realized gains or losses on marketable securities recognized for the year ended December 31, 2022.
The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security's carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statements of operations and comprehensive loss if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company's investment policy, the severity and duration of the impairment and changes in value subsequent to the end of the period. There were no other-than-temporary impairments of investments recognized for the years ended December 31, 2022 or 2021.
Fair Value Measurements
Certain assets of the Company are carried at fair value under 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 (see Note 4). 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.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the estimated useful life of each asset as follows:
Estimated Useful Life
Machinery and equipment 3 to 5 years
Furniture and fixtures 3 to 5 years
Leasehold improvements Shorter of lease term of useful life
Costs for capital assets not yet placed into service are capitalized as construction-in-progress and depreciated in accordance with the above guidelines once placed into service. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is included in loss from operations. Expenditures for repairs and maintenance that do not improve or extend the life of the respective assets are charged to expense as incurred.
Impairment of Long-Lived Assets
Long-lived assets consist of property and equipment. The Company continually evaluates long-lived assets for potential impairment whenever events or changes in circumstances indicate that the carrying value of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the Company compares the carrying values of the asset group to the expected future undiscounted cash flows that the asset group is expected to generate from the use and eventual disposition of the long-lived asset group. An impairment loss would be recognized in loss from operations when estimated undiscounted future cash flows expected to result from the use of an asset group are less than its carrying amount. If such asset group is considered to be impaired, the impairment loss to be recognized would be based on the excess of the carrying value of the impaired asset group over its fair value. The Company did not recognize any impairment losses on long-lived assets during the years ended December 31, 2022 and 2021.
Effective January 1, 2022, the Company adopted ASU No. 2016-02, Leases (Topic 842) ("ASC 842") using the required modified retrospective approach and utilizing the effective date as its date of initial application. As a result, prior periods are presented in accordance with the previous guidance in ASC 840, Leases ("ASC 840").
The Company evaluates whether an arrangement is or contains a lease at the inception date. If determined to be or contain a lease, the Company determines the classification of the lease at the commencement date, which represents the date at which the lessor makes the underlying asset available for use by the Company. When determining the expected accounting lease term, the Company includes the noncancellable lease term, together with periods covered by (i) an option to extend the lease if the Company is reasonably certain to exercise such option, (ii) an option to terminate the lease if the Company is reasonably certain not to exercise such option and (iii) an option to extend or not terminate the lease where the exercise of such option is controlled by the lessor. The Company has elected the short-term lease exemption, which allows the Company to not recognize lease liabilities and right-of-use assets arising from lease arrangements with original lease terms of twelve months or less. The Company elected the practical expedient to not separate lease and non-lease components for its leases.
Right-of-use assets represent the Company's right to use an underlying asset over the lease term and lease liabilities represent the Company's obligation to make lease payments under the arrangement. The Company measures its lease liabilities as the present value of the lease payments, discounted using an incremental borrowing rate, as interest rates implicit in lease arrangements are generally not readily determinable. The Company measures its right-of-use assets as the present value of its lease payments at the commencement date. The incremental borrowing rate represents the interest rate at which the Company could borrow an amount equal to the lease payments on a fully collateralized basis, over a similar term, in a similar economic environment. The Company recognizes rent expense for operating leases on a straight-line basis. The Company recognizes variable lease expenses as incurred.
The Company remeasures right-of-use assets and lease liabilities when a lease is modified, and the modification is not accounted for as a separate contract. A modification is accounted for as a separate contract if the modification grants the Company an additional right of use not included in the original lease arrangement and the increase in lease payments is commensurate with the additional right of use. The Company assesses its right-of-use assets for impairment in a manner consistent with its assessment for long-lived assets held and used in operations.
Costs to secure, defend and maintain patents, including those incurred in connection with filing and prosecuting patent applications, are expensed as incurred due to the uncertainty about the recovery of the expenditure. Amounts incurred for patent-related expenditures are classified as general and administrative expenses.
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is focused on the discovery, development and commercialization of antibody-based solutions for infectious diseases with pandemic potential. The Company's chief operating decision maker reviews the Company's financial information on an aggregated basis for purposes of assessing performance and allocating resources.
Research and Development Expenses
Research and development costs are expensed as incurred. Research and development expenses consist of costs incurred in performing research and development activities, including expenses incurred under agreements with external vendors and consultants engaged to perform non-clinical studies, preclinical studies and clinical trials as well as to manufacture research and development materials for use in such studies and trials; salaries and related personnel costs; stock-based compensation; consultant fees; and third-party license fees.
Nonrefundable advance payments for goods and services to be received in the future for use in research and development activities are recorded as prepaid expenses. The prepaid amounts are expensed as the related goods are delivered or the services are performed, or when it is no longer expected that the goods will be delivered or the services rendered.
Accrued Research and Development Costs
The Company has entered into various research, development and manufacturing contracts with third-party service providers, including contract research organizations and contract manufacturing organizations. With the exception of the Company's manufacturing arrangement with WuXi Biologics (Hong Kong) Limited (see Note 9), these agreements are generally cancelable. The Company recognizes research and development expense associated with such arrangements as the costs are incurred and records accruals for estimated ongoing research, development and manufacturing costs, where necessary. When billing terms under these contracts do not coincide with the timing of when the work is performed, the Company is required to make estimates of outstanding obligations to those third parties as of period end. Any accrual estimates are based on a number of factors, including the Company's knowledge of the progress towards completion of the specific tasks to be performed, invoicing to date under the contracts, communication from the vendors of any actual costs incurred during the period that have not yet been invoiced and the costs included in the contracts. Significant judgments and estimates may be made in determining the accrued balances at the end of any reporting period. Actual results could differ from the estimates made by the Company. The historical accrual estimates made by the Company have not been materially different from the actual costs.
Asset Acquisitions and Acquired In-Process Research and Development Expenses
The Company measures and recognizes asset acquisitions that are not deemed to be business combinations based on the cost to acquire the asset or group of assets, which includes transaction costs. Goodwill is not recognized in asset acquisitions. In an asset acquisition, the cost allocated to acquire in-process research and development ("IPR&D") with no alternative future use is recognized as expense on the acquisition date.
Contingent consideration in asset acquisitions payable in the form of cash is recognized in the period the triggering event is determined to be probable of occurrence and the related amount is reasonably estimable. Such amounts are expensed or capitalized based on the nature of the associated asset at the date the related contingency is resolved.
Stock-Based Compensation
The Company grants stock-based awards to employees, directors and non-employee consultants in the form of stock options to purchase shares of its common stock. The Company measures stock options with service-based vesting granted to employees, non-employees and directors based on the fair value on the date of grant using the Black-Scholes option-pricing model. The Company has issued awards with only service-based vesting conditions through December 31, 2022.
Compensation expense for awards granted to employees and directors for their service on the board of directors is recognized on a straight-line basis over the requisite service period of the respective award, which is generally the vesting period of the award. Compensation expense for awards granted to non-employees is recognized in the same period and manner as if the Company had paid cash for the goods or services provided, which is generally the vesting period of the award. The Company accounts for forfeitures of stock-based awards as they occur.

Frequently Asked Questions

What is the opinion on Invivyd's financial statements?

The financial statements fairly present the company's position as of December 31, 2022, and 2021.

What raised doubts about Invivyd's going concern?

Invivyd has experienced recurring losses and needs additional funding for future operations.

Who is responsible for the consolidated financial statements?

The management of the Company is responsible for the preparation of the financial statements.

How did Invivyd perform in terms of net loss?

Invivyd reported a net loss of $241,317,000 for the year ended December 31, 2022.

What were Invivyd's total assets as of December 31, 2022?

The total assets were $383,167,000 as of December 31, 2022.

Last updated: Feb 9, 2024