What changed in this filing

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Item 1. Financial Statements

2023-11-09 compared with 2023-08-10 · 327 added, 269 removed, 917 unchanged (39% of the section changed)

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(In thousands, except share and per share amounts)

September 30,

Current assets:

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Operating lease liabilities, non-current

Other non-current liability

Early-exercise liability

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10,000,000 shares

authorized and no shares issued and outstanding at June 30, 2023

authorized and no shares issued and outstanding at September 30, 2023

and December 31, 2022

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1,000,000,000 shares authorized,

109,570,333 shares issued and outstanding at June 30, 2023;

109,846,329 shares issued and outstanding at September 30, 2023;

109,044,046 shares issued and outstanding at December 31, 2022

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(In thousands, except share and per share amounts)

Three Months Ended June 30,

Six Months Ended June 30,

Three Months Ended September 30,

Nine Months Ended September 30,

Operating expenses:

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Weighted-average common shares outstanding, basic and diluted

(1) Includes related-party amounts of $ 2,258 and $ 5,218 for the three and six months ended June 30, 2023 , respectively, and $ 2,285 and $ 4,285 for the three and six months ended June 30, 2022 , respectively (see Note 15).

(2) Includes related-party amounts of $ 0 and $ 375 for the three and six months ended June 30, 2023 , respectively, and includes no related-party amounts for both the three and six months ended June 30, 2022 (see Note 15).

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

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

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

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Balances at June 30, 2022

Exercise of stock options

Retirement of treasury stock

Issuance of common stock under the employee stock purchase plan

Stock-based compensation expense

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

Balances at September 30, 2022

Treasury Stock

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Balances at June 30, 2023

Exercise of stock options

Stock-based compensation expense

Issuance of common stock under the employee stock purchase plan

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

Balances at September 30, 2023

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

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(In thousands)

Six Months Ended June 30,

Nine Months Ended September 30,

Cash flows from operating activities:

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Purchases of property and equipment

Net cash provided by investing activities

Net cash provided by (used in) investing activities

Cash flows from financing activities:

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

Operating lease right-of-use asset recognized under ASC 842

Purchases of property and equipment in accounts payable and accrued expenses

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

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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.

The Company’s proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.

Leveraging its INVYMAB platform approach, 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 June and July 2023, the Company announced positive initial data from an ongoing Phase 1 clinical trial of VYD222, a monoclonal antibody (“mAb”) candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.

In May 2023, the Company completed the dosing of all participants in the Phase 1 clinical trial of VYD222.

In May 2023, the Company completed the dosing of all participants in the Phase 1 clinical trial.

Initial Phase 1 data announced in June and July 2023 showed that a single administration of VYD222 was generally well-tolerated at all three dose levels tested with no serious adverse events having been reported.

Serum samples from all dose levels tested in the Phase 1 clinical trial showed robust neutralization activity against Omicron XBB.1.5 at Day 7.

In June 2023, the Company also announced that it had reached general alignment with the U.S.

Food and Drug Administration (the “FDA”) on a pathway to potential emergency use authorization (“EUA”) for VYD222 and anticipated follow-on mAb candidates designed to prevent symptomatic COVID-19.

The Company plans to leverage this pathway in the U.S., and in August 2023, the Company announced its plans to initiate a pivotal clinical trial of VYD222, referred to as the CANOPY trial, using a surrogate endpoint to generate the clinical data needed to enable a potential EUA submission for the prevention of symptomatic COVID-19.

The Company plans to leverage this pathway in the U.S., which includes the use of serum neutralizing titers as a correlate of protection (surrogate of clinical efficacy) in an immunobridging approach to a pivotal clinical trial of VYD222.

In September 2023, the Company announced dosing of the first participant in a Phase 3 pivotal clinical trial of VYD222, referred to as the CANOPY clinical trial, which is designed to evaluate protection against symptomatic COVID-19 after receiving VYD222.

The safety, tolerability, pharmacokinetic profile, and immunogenicity of VYD222 will also be evaluated.

The CANOPY clinical trial is designed to rapidly generate the clinical data needed to enable a potential EUA submission for VYD222.

In November 2023, the Company announced the completion of enrollment in the CANOPY clinical trial, with approximately 750 participants enrolled in two cohorts (A and B) across multiple trial sites in the U.S.

In Cohort A, the Company enrolled approximately 300 participants who are significantly immunocompromised.

The primary efficacy endpoint for Cohort A will be serum neutralizing titers against relevant SARS-CoV-2 variants at Day 28, which will be calculated based on the pharmacokinetic concentration of VYD222 from the immunocompromised participants and the IC 50 value for VYD222 against relevant SARS-CoV-2 variants.

In Cohort B, the Company enrolled approximately 450 participants at risk of exposure to SARS-CoV-2.

The primary endpoint for Cohort B will be safety and tolerability.

The Company expects to have initial primary endpoint data from the CANOPY clinical trial by late 2023 or early in the first quarter of 2024.

Given the urgent unmet medical need, the Company aims to submit an application for an EUA for VYD222 to the FDA as soon as practicable.

The Company is actively preparing for the potential commercial launch of VYD222 in the U.S.

in 2024, if authorized.

VYD222 is the Company’s second mAb candidate to enter clinical testing.

VYD222 was designed for broad activity and 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 designed for broad activity and has demonstrated in vitro neutralizing activity against various pre-Omicron and Omicron variants, such as XBB.1.5, XBB.1.16, and XBB.1.5.10, an Omicron variant that has the same spike glycoprotein sequence as EG.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 2/3 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 optimized to stay ahead of the evolving SARS-CoV-2 virus.

Beyond VYD222, the Company plans to leverage its INVYMAB platform approach to produce additional mAb candidates optimized to stay ahead of the evolving SARS-CoV-2 virus.

The Company has multiple anti-SARS-CoV-2 mAb candidates in the discovery/preclinical stage.

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.

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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 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 authorization or 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.

The Company’s product candidates require significant additional research and development efforts, including extensive clinical testing and regulatory authorization or approval prior to commercialization.

These efforts require significant amounts of additional capital, adequate personnel and infrastructure and compliance-reporting capabilities.

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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 $ 85.5 million for the six months ended June 30, 2023.

As of June 30, 2023, the Company had an accumulated deficit of $ 619.0 million.

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 $ 125.0 million for the nine months ended September 30, 2023.

As of September 30, 2023, the Company had an accumulated deficit of $ 658.4 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.

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 these interim condensed consolidated financial statements.

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.

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The full impact of the COVID-19 pandemic remains uncertain, and such impact may directly or indirectly affect the potential commercial prospects of VYD222 and other product candidates for the prevention and treatment of COVID-19.

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 may affect the design and enrollment of the Company’s clinical trials, the potential regulatory authorization or approval of the Company’s product candidates, the availability of funding and partnership opportunities, and the commercialization of the Company’s product candidates, if authorized or approved.

The evolution of the disease and the continued emergence of variants of concern (“VoCs”), and the availability, administration and acceptance of vaccines, mAbs, antiviral agents, and other therapeutic modalities may affect the design and enrollment of the Company’s clinical trials, the potential regulatory authorization or approval of the Company’s product candidates, the availability of funding and partnership opportunities, and the commercialization of the Company’s product candidates, if authorized or approved.

In addition, the Company’s business and operations may be more broadly adversely affected by the COVID-19 pandemic.

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Summary of Significant Accounting Policies

As of June 30, 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.

As of September 30, 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.

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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.

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Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of June 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the condensed consolidated statements of cash flows for the six months ended June 30, 2023 and 2022 and the condensed consolidated statements of stockholders’

equity (deficit) for the three and six months ended June 30, 2023 and 2022 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of June 30, 2023, and for the three and six months ended June 30, 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 September 30, 2023, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022 and the condensed consolidated statements of stockholders’

equity (deficit) for the three and nine months ended September 30, 2023 and 2022 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of September 30, 2023, and for the three and nine months ended September 30, 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.

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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 June 30, 2023 and December 31, 2022, the condensed consolidated results of operations for the three and six months ended June 30, 2023 and 2022, the condensed consolidated cash flows for the six months ended June 30, 2023 and 2022 and changes in stockholders’

equity (deficit) for the six months ended June 30, 2023 and 2022 have been made.

The Company’s condensed consolidated results of operations for the three and six months ended June 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023 .

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 September 30, 2023 and December 31, 2022, the condensed consolidated results of operations for the three and nine months ended September 30, 2023 and 2022, the condensed consolidated cash flows for the nine months ended September 30, 2023 and 2022 and changes in stockholders’

equity (deficit) for the nine months ended September 30, 2023 and 2022 have been made.

The Company’s condensed consolidated results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023 .

Use of Estimates

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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 six months ended June 30, 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.

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 nine months ended September 30, 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.

Marketable Securities

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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 June 30, 2023 and December 31, 2022 (in thousands):

June 30, 2023

The following tables summarize the gross unrealized gains, unrealized losses and credit losses of the Company’s marketable securities as of September 30, 2023 and December 31, 2022 (in thousands):

September 30, 2023

Amortized Cost

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Total financial assets

The Company did not record any charges for credit-related impairments for its available-for-sale securities during the three and six months ended June 30, 2023.

No available-for-sale marketable securities held as of June 30, 2023 or December 31, 2022 had remaining maturities greater than twelve months.

The Company did not record any charges for credit-related impairments for its available-for-sale securities during the three and nine months ended September 30, 2023 .

No available-for-sale marketable securities held as of September 30, 2023 or December 31, 2022 had remaining maturities greater than twelve months.

Fair Value Measurements

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Fair Value Measurements at

June 30, 2023:

September 30, 2023:

Cash equivalents:

Money market funds

Federal agency securities

Marketable securities:

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government agency securities and no exchange exists to price such investments, they are recognized as Level 2 assets.

There were no changes to the valuation methods during the three and six months ended June 30, 2023 or 2022.

There were no changes to the valuation methods during the three and nine months ended September 30, 2023 or 2022.

The Company evaluates transfers between levels at the end of each reporting period.

There were no transfers into or out of Level 1, Level 2 or Level 3 fair value measurements during the three and six months ended June 30, 2023 or 2022.

There were no transfers into or out of Level 1, Level 2 or Level 3 fair value measurements during the three and nine months ended September 30, 2023 or 2022.

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following (in thousands):

September 30,

Prepaid external research, development and manufacturing costs

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Accrued expenses consisted of the following (in thousands):

September 30,

Accrued external research, development and manufacturing costs

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Under the terms of the agreement, Adimab assigned to the Company all rights, title and interest in and to certain of its coronavirus-specific antibodies (each, a “CoV Antibody”

and together, the “CoV Antibodies”), including modified or derivative forms thereof, and related intellectual property (“Adimab CoV Assets”).

and together, the “CoV Antibodies”), including modified or derivative forms thereof, and related intellectual property.

In addition, Adimab granted to the Company a non-exclusive, worldwide, royalty-bearing, sublicensable license to certain of its platform patents and technology for the development, manufacture and commercialization of the CoV Antibodies and pharmaceutical products containing or comprising one or more CoV Antibodies (each, a “Product”) for all indications and uses, with the exception of certain diagnostic uses and use as a research reagent (the “Field”).

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Amounts paid with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement are recognized as research and development expense as such amounts are incurred.

During the three and six months ended June 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company's behalf under the Adimab Assignment Agreement.

During the three and six months ended June 30, 2022 , the Company recognized $ 0.2 million and $ 0.5 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement.

During the three and nine months ended September 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement.

During the three and nine months ended September 30, 2022 , the Company recognized $ 0.1 million and $ 0.6 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement.

Please refer to Note 15 for additional information.

The Company is obligated to pay Adimab up to $ 16.5 million upon the achievement of specified development and regulatory milestones for the first Product under the agreement that achieves such specified milestones and up to $ 8.1 million upon the achievement of specified development and regulatory milestones for the second Product under the agreement that achieves such specified milestones.

The maximum aggregate amount of milestone payments payable under the agreement for any and all Products is $ 24.6 million , of which $ 7.9 million had been paid as of June 30, 2023;

The maximum aggregate amount of milestone payments payable under the agreement for any and all Products is $ 24.6 million , of which a total of $ 11.1 million has been achieved and $ 7.9 million had been paid as of September 30, 2023;

however, milestone payments do not accrue for certain in vitro diagnostic devices consisting of or containing CoV Antibodies.

In March 2023, the Company achieved the first specified milestone for the second product candidate under the Adimab Assignment Agreement upon dosing of the first subject in a Phase 1 clinical trial evaluating VYD222, which obligated the Company to make a $ 0.4 million milestone payment to Adimab.

During the three and six months ended June 30, 2023, the Company recognized $ 0 and $ 0.4 million, respectively, of in-process research and development (“IPR&D”) expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

During the three and six months ended June 30, 2022, the Company did not recognize any IPR&D expense in connection with contingent consideration payable under the Adimab Assignment Agreement.

The next potential milestone under the Adimab Assignment Agreement is a low single-digit million-dollar milestone related to dosing of the first subject in a pivotal trial evaluating VYD222, which was not considered probable under U.S.

GAAP and therefore, no expense was recognized as of June 30, 2023.

The Company is obligated to pay Adimab royalties of a mid-single-digit percentage based on net sales of any Products, once commercialized.

In September 2023, the Company achieved specified milestones for the second product candidate under the Adimab Assignment Agreement upon dosing of the first subject in a pivotal clinical trial evaluating VYD222, which obligated the Company to make a $ 3.2 million milestone payment to Adimab, which was paid in October 2023.

During the three and nine months ended September 30, 2023 , the Company recognized $ 3.2 million and $ 3.6 million, respectively, of in-process research and development (“IPR&D”) expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

During the three and nine months ended September 30, 2022, the Company did not recognize any IPR&D expense in connection with contingent consideration payable under the Adimab Assignment Agreement.

The next potential milestone under the Adimab Assignment Agreement is a low single-digit million-dollar regulatory milestone, which was not considered probable under U.S.

GAAP and therefore, no expense was recognized as of September 30, 2023.

The Company is obligated to pay Adimab royalties of a mid-single-digit percentage based on net sales of any Products, beginning upon the first commercial sale of a Product in accordance with the Adimab Assignment Agreement .

The royalty rate is subject to reductions specified under the agreement.

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In addition, the Company is obligated to pay Adimab royalties of a specified percentage in the range of 45 % to 55 % of any compulsory sublicense consideration received by the Company in lieu of certain royalty payments.

Except for milestone payments of $ 7.5 million incurred through December 31, 2022 and a $ 0.4 million milestone payment incurred during the three months ended March 31, 2023, no other milestone, royalty or other contingent payments had become due to Adimab through June 30, 2023.

Except for milestone payments of $ 7.5 million incurred

through December 31, 2022, and milestone payments of $ 3.6 million incurred during the nine months ended September 3 0, 2023 , no other milestone, royalty or other contingent payments had become due to Adimab through September 30, 2023.

Unless earlier terminated, the Adimab Assignment Agreement remains in effect until the expiration of the last-to-expire Royalty Term for any and all Products.

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Adimab Collaboration Agreement

In May 2021, the Company entered into a Collaboration Agreement with Adimab, as amended in November 2022 (the “Adimab Collaboration Agreement”), for the discovery and optimization of proprietary antibodies as potential therapeutic product candidates.

In May 2021, the Company entered into a Collaboration Agreement with Adimab, as amended in November 2022 and September 2023 (the “Adimab Collaboration Agreement”), for the discovery and optimization of proprietary antibodies as potential therapeutic product candidates.

Under the Adimab Collaboration Agreement, the Company and Adimab will collaborate on research programs for a specified number of targets selected by the Company within a specified time period.

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The Company may also elect to decrease the scope of Adimab’s exclusivity obligations and obtain a corresponding decrease in the quarterly fee.

During the three and six months ended June 30, 2023 , the Company recognized $ 1.3 million and $ 2.6 million, respectively, of research and development expense related to the quarterly fee.

During the three and six months ended June 30, 2022 , the Company recognized $ 1.3 million and $ 2.6 million, respectively, of research and development expense related to the quarterly fee.

During the three and nine months ended September 30, 2023 , the Company recognized $ 1.3 million and $3 .9 million, respectively, of research and development expense related to the quarterly fee.

During the three and nine months ended September 30, 2022 , the Company recognized $ 1.3 million and $ 3.9 million, respectively, of research and development expense related to the quarterly fee.

For each agreed upon research program that is commenced, the Company is obligated to pay Adimab quarterly for its services performed during a given research program at a specified full-time equivalent rate;

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Amounts paid with respect to services performed by Adimab on the Company’s behalf in each of the research programs under the Adimab Collaboration Agreement are recognized as research and development expense as such amounts are incurred and services are rendered.

During the three and six months ended June 30, 2023 , the Company recognized $ 0.2 million and $ 0.4 million, respectively, of research and development expense with respect to services performed by Adimab on the Company's behalf under the Adimab Collaboration Agreement.

During the three and six months ended June 30, 2022, the Company recognized $ 0.6 million and $ 1.0 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.

During both the three and six months ended June 30, 2023 and 2022, the Company did no t recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees.

During the three and six months ended June 30, 2023, the Company did not recognize any research and development expense related to a drug discovery fee.

During the three and six months ended June 30, 2022, the Company recognized $ 0.2 million of research and development expense related to a drug delivery fee.

During the three and nine months ended September 30, 2023 , the Company recognized $ 0.1 million and $ 0.5 million, respectively, of research and development expense with respect to services performed by Adimab on the Company ’s behalf under the Adimab Collaboration Agreement.

During the three and nine months ended September 30, 2022 , the Company recognized $ 0.3 million and $ 1.3 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.

During both the three and nine months ended September 30, 2023, the Company recognized $ 1.0 million, $ 0.2 million, and $ 0.2 million of IPR&D expense related to an option exercise fee, a drug delivery fee and an optimization completion fee, respectively.

During both the three and nine months ended September 30, 2022, the Company recognized $ 1.0 million of IPR&D expense related to an option exercise fee.

During the three and nine months ended September 30, 2022, the Company recognized $ 0 and $ 0.2 million, respectively, of research and development expense related to a drug delivery fee.

Please refer to Note 15 for additional information.

The Company is obligated to pay Adimab up to $ 18.0 million upon the achievement of specified development and regulatory milestones for each product under the Adimab Collaboration Agreement that achieves such milestones.

The next potential milestone under the Adimab Collaboration Agreement is a low single-digit million-dollar milestone related to dosing of the first subject in a Phase 1 trial, which was not considered probable under U.S.

GAAP and therefore, no expense was recognized as of June 30, 2023.

The next potential milestone under the Adimab Collaboration Agreement is a low single-digit million-dollar clinical milestone, which was not considered probable

GAAP and therefore, no expense was recognized as of September 30, 2023.

The Company is also obligated to pay Adimab royalties of a mid-single-digit percentage based on net sales of any product under the Adimab Collaboration Agreement, subject to reductions for third-party licenses.

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In consideration for this work, the Company is obligated to pay Adimab royalties of a low single-digit percentage based on net sales of products that contain such antigens for the same royalty term as antibody-based products, but the Company is not obligated to make any milestone payments for such antigen products.

Through June 30, 2023, the Company had not paid any royalties to Adimab under the Adimab Collaboration Agreement.

Through September 30, 2023, the Company had not paid any royalties to Adimab under the Adimab Collaboration Agreement.

The Adimab Collaboration Agreement will expire (i) if the Company does not exercise any option, upon the conclusion of the last Evaluation Term for the research programs, or (ii) if the Company exercises an option, on the expiration of the last royalty term for a product in a particular country, unless the agreement is earlier terminated.

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The Company is obligated to pay Adimab an annual fee of single digit millions on each of the first four anniversaries of the Effective Date, which will allow the Company to receive material improvements to the platform technology, including materially improved antibody optimization libraries, updates that provide new functionality to the platform, and software upgrades, from Adimab through June 2027.

The first annual fee will become due in September 2023.

The first annual fee became due in September 2023 and was paid in October 2023.

During both the three and nine months ended September 30, 2023, the Company recognized a portion of the first annual fee as research and development expense.

Beginning in July 2027 and ending in June 2042, unless terminated earlier, the Company has the option to receive additional material improvements to the platform technology from Adimab, subject to a commercially reasonable fee to be negotiated by the parties.

The Company is obligated to pay Adimab up to $ 9.5 million upon the achievement of specified development and regulatory milestones for each product under the Adimab Platform Transfer Agreement that achieves such milestones.

The next potential milestone under the Adimab Platform Transfer Agreement is a mid-six-digit dollar milestone related to the start of IND-enabling toxicology studies, which was not considered probable under U.S.

GAAP and therefore, no expense was recognized as of June 30, 2023.

In addition, the Company is obligated to pay Adimab royalties of a low single-digit percentage based on net sales of products containing an antibody discovered, engineered or optimized using Adimab’s platform technology, once commercialized.

The royalty rate is subject to reductions specified under the Adimab Platform Transfer Agreement.

The next potential milestone under the Adimab Platform Transfer Agreement is a mid-six-digit dollar preclinical milestone, which was not considered probable under U.S.

GAAP and therefore, no expense was recognized as of September 30, 2023.

Royalties are due on a product-by-product and country-by-country basis.

The royalty term will expire for each product on a country-by-country basis upon the later of (i) 12 years after the first commercial sale of such product in such country and (ii) the expiration of the last valid claim of a program antibody patent for covering the program antibody contained in such product in such country.

Through June 30, 2023, the Company had not paid any royalties to Adimab under the Adimab Platform Transfer Agreement.

Through September 30, 2023, the Company had not paid any royalties to Adimab under the Adimab Platform Transfer Agreement.

The Company may terminate the Adimab Platform Transfer Agreement at any time upon advance written notice to Adimab.

13 unchanged sentences

Royalties are due on a Licensed Product-by-Licensed Product basis commencing on the date of the first commercial sale of the applicable product and continuing for so long as the Company commercializes Licensed Products or, if earlier, until the Company exercises its option to buy out the royalty obligations.

Through June 30, 2023 , no royalties had become due to WuXi Biologics.

Through September 30, 2023 , no royalties had become due to WuXi Biologics.

The Cell Line License Agreement remains in effect until it is terminated.

5 unchanged sentences

The Cell Line License Agreement did not qualify as a business combination because substantially all of the fair value of the assets acquired was concentrated in a single asset.

Therefore, the $ 0.2 million and $ 0.6 million of license fees was recognized as IPR&D expense during the three and six months ended June 30, 2023, respectively.

Therefore, the $ 0 and $ 0.6 million of license fees were recognized as IPR&D expense during the three and nine months ended September 30, 2023, respectively.

Research Collaboration and License Agreement with The Scripps Research Institute

5 unchanged sentences

Amounts incurred for services performed by TSRI under the Research Agreement were expensed to research and development expense as the services were rendered.

During the three and six months ended June 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed under the Research Agreement as it was terminated during 2022.

During the three and six months ended June 30, 2022 , the Company recognized $ 0.8 million and $ 1.7 million, respectively, of research and development expense with respect to services performed under the Research Agreement.

During the three and nine months ended September 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed under the Research Agreement as it was terminated during 2022.

During the three and nine months ended September 30, 2022 , the Company recognized $ 0 and $ 1.7 million, respectively, of research and development expense with respect to services performed under the Research Agreement.

Population Health Partners, L.P

1 unchanged sentence

(“PHP”), pursuant to which PHP agreed to provide services and create deliverables for the Company as agreed between the Company and PHP and set forth in one or more work orders under such agreement (the “PHP MSA”).

The term of the PHP MSA commenced on the PHP Effective Date and will continue for a period of one year, unless terminated earlier in accordance with its terms.

The term of the PHP MSA

commenced on the PHP Effective Date and will continue for a period of one year, unless terminated earlier in accordance with its terms.

On the PHP Effective Date, the Company and PHP entered into the first work order under the PHP MSA (the “PHP Work Order”), pursuant to which PHP agreed to advise and counsel the Company regarding clinical development and regulatory matters with respect to the Company’s product candidates.

2 unchanged sentences

As compensation for the services and deliverables under the PHP Work Order, the Company paid PHP a cash fee of $ 0.5 million per month during the term of the PHP Work Order for an aggregate fee of $ 3.0 million (the “Aggregate Fee”).

During the three and six months ended June 30, 2023, the Company recognized $ 0.8 million and $ 2.3 million, respectively, of research and development expense related to the cash compensation paid to PHP.

During the three and nine months ended September 30, 2023, the Company recognized $ 0 and $ 2.3 million, respectively, of research and development expense related to the cash compensation paid to PHP.

Please refer to Note 15 for additional information.

In addition to the cash compensation, on the PHP Effective Date, the Company issued a warrant to purchase shares of the Company’s common stock to PHP (the “PHP Warrant”).

The exercise price of the PHP Warrant is $ 3.48 per share of the Company’s

common stock, which is equal to the Nasdaq official closing price (as defined in the PHP Warrant) of a share of the Company’s common stock on the trading day immediately prior to the PHP Effective Date.

The exercise price of the PHP Warrant is $ 3.48 per share of the Company’s common stock, which is equal to the Nasdaq official closing price (as defined in the PHP Warrant) of a share of the Company’s common stock on the trading day immediately prior to the PHP Effective Date.

The PHP Warrant is exercisable for up to an aggregate of 6,824,712 shares of the Company’s common stock, and vests in three separate tranches as follows:

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The monthly rental payments under the lease, which include base rent charges of $ 0.4 million per year, are subject to periodic rent increases through September 2026.

In addition to base rent, monthly rental payments include the Company’s proportionate share of operating expenses.

In addition to base rent, monthly rental payments include

the Company’s proportionate share of operating expenses.

The lease terms provide for one five-year extension term with base rent calculated on the then-market rate.

11 unchanged sentences

For the Three Months

Ended June 30,

Ended September 30,

For the Three Months

Ended June 30,

For the Six Months

Ended June 30,

For The Six Months

Ended June 30,

Ended September 30,

For the Nine Months

Ended September 30,

For The Nine Months

Ended September 30,

Operating lease cost

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Operating cash flows related to operating leases

Future minimum lease payments under the noncancelable leases as of June 30, 2023 was as follows (in thousands):

Future minimum lease payments under the noncancelable leases as of September 30, 2023 was as follows (in thousands):

Year Ending December 31,

Operating Lease

2023 (excluding the six months ended June 30, 2023)

2023 (excluding the nine months ended September 30, 2023)

Total lease payments

1 unchanged sentence

Present value of operating lease liability

As of June 30, 2023 , the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted-average remaining lease term of 2.2 years.

As of June 30, 2022 , the Company’s operating lease was measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted average remaining lease term of 3.2 years.

As of September 30, 2023 , the Company’s operating leases were measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted-average remaining lease term of 2.0 years.

As of September 30, 2022 , the Company’s operating lease was measured using a weighted-average incremental borrowing rate of 6.0 % over a weighted average remaining lease term of 4.0 years.

The total operating liabilities are presented on the Company’s condensed consolidated balance sheet based on maturity dates.

12 unchanged sentences

The Clinical Master Services Agreement outlines the terms and conditions under which WuXi Biologics coordinates biologics development and clinical manufacturing services for the Company.

In December 2020, the Company entered into a Commercial Manufacturing Services Agreement with WuXi Biologics, which was amended and restated in August 2021 (as amended and restated, the “Commercial Manufacturing Agreement”).

The Commercial Manufacturing Agreement outlines the terms and conditions under which WuXi Biologics manufactures adintrevimab drug substance and drug product for commercial use.

In December 2020, the Company entered into a Commercial Manufacturing Services Agreement with WuXi Biologics, which was amended and restated in August 2021 and further amended and restated in September 2023 (as amended and restated, the “Commercial Manufacturing Agreement”).

The Commercial Manufacturing Agreement outlines the terms and conditions under which WuXi Biologics manufactures drug substance and drug product for commercial use.

The Company committed to minimum noncancelable purchase obligations related to batches of adintrevimab drug substance and certain services with respect to the product requirements for 2022 and 2023 and batches of drug product and certain services with respect to the product requirements for 2022, the payments for which have extended into 2023.

5 unchanged sentences

In March 2023, the remaining amount of the low eight-figure credit was applied to WuXi Biologics services as a reduction of research and development expenses and a reduction of accounts payable.

As of June 30, 2023, the total remaining cost of contractually binding VYD222 drug substance batches to be manufactured under the Clinical Master Services Agreement was less than $ 0.1 million, which is expected to be incurred and paid in 2023.

As of June 30, 2023, $ 8.9 million related to the contractually binding VYD222 drug substance batches was included in accounts payable and accrued expenses, which is expected to be paid in the second half of 2023.

As of September 30, 2023, there were no remaining costs of contractually binding VYD222 drug substance batches to be manufactured under the Clinical Master Services Agreement.

As of September 2023, $ 0.1 million related to the contractually binding VYD222 drug substance batches was included in accounts payable and accrued expenses, which is expected to be paid in the fourth quarter of 2023.

In June 2023, the Company committed to a noncancelable purchase obligation related to the procurement of resin for future use in VYD222 drug substance batches under the Commercial Manufacturing Agreement.

The total costs of contractually binding resin to be incurred by the Company is $ 10.4 million.

In July 2023, the Company committed to a noncancelable purchase obligation related to the procurement of materials to be used in VYD222 drug substance and drug product batches under the Commercial Manufacturing Agreement.

The total costs of contractually binding materials to be incurred by the Company is $ 4.3 million.

Unless earlier terminated, the Commercial Manufacturing Agreement remains in effect for an initial period of five years and thereafter automatically renews for further successive periods of five years each.

Either party may terminate the agreement upon the breach or default by the other party, other than a non-payment breach, that is not cured within 90 days after notice.

As of September 30, 2023, the total costs of contractually binding resin to be incurred by the Company was $ 10.4 million.

During the three months ended September 30, 2023, the Company committed to noncancelable purchase obligations related to the procurement of materials to be used in VYD222 drug substance and drug product batches under the Commercial Manufacturing Agreement.

As of September 30, 2023, the total costs of contractually binding materials to be incurred by the Company was $ 5.7 million.

In September 2023, the Company committed to a noncancelable purchase obligation related to commercial VYD222 drug substance batches under the Commercial Manufacturing Agreement.

As of September 30, 2023, the total costs of contractually binding commercial VYD222 drug substance batches to be incurred by the Company was $ 34.8 million.

Unless earlier terminated, the Commercial Manufacturing Agreement remains in effect for an initial period of five years from the date of the last amendment and restatement of the agreement and thereafter automatically renews for further successive periods of five years each.

Either party may terminate the agreement upon the breach or default by the other party, other than a non-payment breach, that is not timely cured after notice thereof.

Both parties are also entitled to terminate the Commercial Manufacturing Agreement if the other party becomes insolvent or is the subject of a petition in bankruptcy or of any other related proceeding or event.

Either party may terminate either the Commercial Manufacturing Agreement in its entirety, or an individual order, (i) to the extent the other party suffers a force majeure event that is continuing for a predefined period of time and (ii) if the other party fails to make a payment when due under the arrangement and such non-payment is not cured within 30 days after notice.

Until regulatory approval and future economic benefit is probable, the Company will continue to expense costs related to batches manufactured under the Commercial Manufacturing Agreement.

5 unchanged sentences

The actual amounts the Company could pay in the future to the vendors under such agreements may differ from the purchase order amounts due to cancellation provisions.

The termination fees were not probable of payment as of June 30, 2023 and December 31, 2022.

The termination fees were not probable of payment as of September 30, 2023 and December 31, 2022.

Legal Proceedings

11 unchanged sentences

fees, expert fees, and other costs.

The court appointed lead plaintiffs for the action on June 28, 2023, and has set an August 23, 2023 deadline for lead plaintiffs to file an amended complaint.

The court appointed lead plaintiffs for the action on June 28, 2023.

On August 23, 2023, the lead plaintiffs filed an amended complaint that makes allegations similar to those in the original complaint and asserts the same claims against the same defendants as the original complaint.

On October 19, 2023, the parties filed a joint stipulation to advise the court that the lead plaintiffs intend to seek leave to file a second amended complaint;

by November 17, 2023, the parties will file a stipulation regarding the filing of the proposed second amended complaint and a briefing schedule for defendants’

response thereto.

The Company believes that is has strong defenses, and it intends to vigorously defend against this action.

The lawsuit is in early stages, and, at this time, no assessment can be made as to the likely outcome or whether the outcome will be material to the Company.

Additionally, the Company received a request from the SEC, dated March 22, 2023, for documents and information concerning, among other matters, the Company’s testing and analysis of the efficacy of ADG20 against Omicron and other COVID-19 variants, its public statements regarding the potential use of ADG20 against the Omicron variant, and related communications with investors and the media.

By letter dated August 9, 2023, the SEC notified the Company that the SEC had concluded its investigation and does not intend to recommend any action against the Company.

Indemnification Agreements

4 unchanged sentences

Shares Reserved for Future Issuance

As of June 30, 2023 , the Company had reserved 43,638,367 shares of common stock for the exercise of outstanding stock options and the issuance of awards available for grant under the Company’s 2020 Equity Incentive Plan, 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan (see Note 11).

As of September 30, 2023 , the Company had reserved 43,362,371 shares of common stock for the exercise of outstanding stock options and the issuance of awards available for grant under the Company’s 2020 Equity Incentive Plan, 2021 Equity Incentive Plan and 2021 Employee Stock Purchase Plan (see Note 11).

Shelf Registration Statement

1 unchanged sentence

333-267643) and an accompanying base prospectus, which was declared effective by the SEC on October 5, 2022, for the offer and sale of up to $ 400 million of the Company’s securities.

As of September 30, 2023, $ 400 million of the Company’s securities remained available for offer and sale under this shelf registration statement.

Treasury Stock

12 unchanged sentences

Upon retirement, the shares were redesignated as authorized but unissued shares of the Company’s common stock.

In October 2023, the Company repurchased 31,766 shares of unvested restricted common stock at the original purchase price upon a termination of service of an employee during the vesting period.

The shares of common stock repurchased were recorded as treasury stock.

Stock-Based Compensation

8 unchanged sentences

Certain awards of stock options permit the holders to exercise the option in whole or in part prior to the full vesting of the option in exchange for unvested shares of restricted common stock with respect to any unvested portion of the option so exercised.

As of June 30, 2023, there were 6,742,631 shares authorized to be issued upon the exercise of outstanding stock option grants and no shares reserved for future issuance under the 2020 Plan.

As of September 30, 2023, there were 6,273,185 shares authorized to be issued upon the exercise of outstanding stock option grants and no shares reserved for future issuance under the 2020 Plan.

2021 Equity Incentive Plan

5 unchanged sentences

On January 1, 2022, 5,539,145 shares of common stock were automatically added to the shares authorized for issuance under the 2021 Plan.

The number of shares to be issued under the 2021 Plan did not increase on January 1, 2023 as determined by the Company's board of directors.

The number of shares to be issued under the 2021 Plan did not increase on January 1, 2023 as determined by the Company ’s board of directors.

The shares of common stock underlying any awards that are forfeited, cancelled, held back upon exercise or settlement of an award to satisfy the exercise price or tax withholding, repurchased or are otherwise terminated by the Company under the 2021 Plan will be added back to the shares of common stock available for issuance under the 2021 Plan.

As of June 30, 2023 , there was an aggregate of 42,510,161 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which includes 6,742,631 and 15,078,617 shares authorized to be issued upon the exercise of outstanding stock option grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 20,688,913 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively.

As of September 30, 2023 , there was an aggregate of 42,279,870 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which includes 6,273,185 and 15,773,163 shares authorized to be issued upon the exercise of outstanding stock option grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 20,233,522 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively.

Stock Option Valuation

6 unchanged sentences

Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award.

Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.

The following table presents, on a weighted-average basis, the assumptions used in the Black-Scholes option-pricing model to determine the grant date fair value of stock options granted:

Three Months Ended

September 30,

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Expected term (in years)

6 unchanged sentences

Outstanding at December 31, 2022

Outstanding at June 30, 2023

Vested and expected to vest at June 30, 2023

Options exercisable at June 30, 2023

The weighted-average grant date fair value of stock options granted during the three and six months ended June 30, 2023 was $ 0.86 and $ 1.18 , respectively, per share.

The weighted-average grant date fair value of stock options granted during the three and six months ended June 30, 2022 was $ 2.07 and $ 3.88 , respectively, per share.

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the common stock for the options that had exercise prices lower than the estimated fair value of the Company's common stock at June 30, 2023 and 2022.

The total intrinsic value of stock options exercised was $ 0.1 million and $ 0.4 million for the three and six months ended June 30, 2023 , respectively.

The total intrinsic value of stock options exercised was $ 0.3 million and $ 0.6 million for the three and six months ended June 30, 2022, respectively.

Outstanding at September 30, 2023

Vested and expected to vest at September 30, 2023

Options exercisable at September 30, 2023

The weighted-average grant date fair value of stock options granted during the three and nine months ended September 30, 2023 was $ 1.06 and $ 1.15 , respectively, per share.

The weighted-average grant date fair value of stock options granted during the three and nine months ended September 30, 2022 was $ 2.28 and $ 3.50 , respectively, per share.

The total intrinsic value of stock options exercised was $ 0.1 million and $ 0.5 million for the three and nine months ended September 30, 2023 , respectively.

The total intrinsic value of stock options exercised was $ 0.4 million and $ 1.0 million for the three and nine months ended September 30, 2022, respectively.

Early Exercise of Stock Options into Restricted Stock

The Company’s restricted stock activity during the six months ended June 30, 2023 was solely due to shares of restricted common stock issued pursuant to the permitted early exercise of stock options as permitted under the 2020 Plan prior to amendments to the 2020 Plan.

The Company’s restricted stock activity during the nine months ended September 30, 2023 was solely due to shares of restricted common stock issued pursuant to the permitted early exercise of stock options as permitted under the 2020 Plan prior to amendments to the 2020 Plan.

The 2021 Plan does not permit early exercise of stock options.

3 unchanged sentences

Unvested restricted stock at December 31, 2022

Unvested restricted stock at June 30, 2023

Unvested restricted stock at September 30, 2023

Proceeds from the early exercise of stock options are recorded as an early-exercise liability on the condensed consolidated balance sheets.

The liability for unvested common stock subject to repurchase is then reclassified to common stock and additional paid-in capital as the Company’s repurchase right lapses.

Shares issued pursuant to the early exercise of stock options are not considered to be outstanding for accounting purposes until the shares vest.

As of both June 30, 2023 and December 31, 2022 , the liability related to the payments for unvested shares from early-exercised options was less than $ 0.1 million.

Shares issued pursuant to the early exercise of stock options are not considered to be

outstanding for accounting purposes until the shares vest.

As of both September 30, 2023 and December 31, 2022 , the liability related to the payments for unvested shares from early-exercised options was less than $ 0.1 million.

Stock-Based Compensation Expense

1 unchanged sentence

Three Months Ended

September 30,

Three Months Ended

Six Months Ended

September 30,

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Research and development

Selling, general and administrative

As of June 30, 2023 , total unrecognized stock-based compensation expense related to unvested stock-based awards was $ 42.7 million, which is expected to be recognized over a weighted-average period of 2.6 years.

As of September 30, 2023 , total unrecognized stock-based compensation expense related to unvested stock-based awards was $ 37.3 million, which is expected to be recognized over a weighted-average period of 2.5 years.

2021 Employee Stock Purchase Plan

1 unchanged sentence

A total of 1,342,773 shares of common stock were initially reserved for issuance under the 2021 ESPP.

There were 214,567 shares issued under the 2021 ESPP as of June 30, 2023 .

There were 260,272 shares issued under the 2021 ESPP as of September 30, 2023 .

The number of shares of common stock that may be issued under the 2021 ESPP will automatically increase on the first day of each calendar year, beginning on January 1, 2022 and continuing through January 1, 2031, by an amount equal to the lesser of (i) 1 % of the shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, (ii) 2,685,546 shares and (iii) an amount determined by the Company’s board of directors.

The number of shares to be issued under the 2021 ESPP did not increase on January 1, 2023 as determined by the Company's b oard of directors.

The number of shares to be issued under the 2021 ESPP did not increase on January 1, 2023 as determined by the Company’s b oard of directors.

The first offering under the 2021 ESPP was June 6, 2022.

As of June 30, 2023 , 1,128,206 shares remained available for issuance under the 2021 ESPP.

During the three and six months ended June 30, 2023, the Company recognized less than $ 0.1 million in related stock-based compensation expense.

As of September 30, 2023 , 1,082,501 shares remained available for issuance under the 2021 ESPP.

During the three and nine months ended September 30, 2023, the Company recognized less than $ 0.1 million and $ 0.1 million, respectively, in related stock-based compensation expense.

Warrant Expense

5 unchanged sentences

The aggregate grant date fair value of the PHP Warrant was $ 17.4 million, which was recognized as warrant expense on the grant date in November 2022.

There were no warrants issued during the three and six months ended June 30, 2023.

As of June 30, 2023 , there were 6,824,712 warrants outstanding at a weighted average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 9.39 years.

For the three and six months ended June 30, 2023 and 2022, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period, due to its uncertainty of realizing a benefit from those items.

There were no warrants issued during the three and nine months ended September 30, 2023.

As of September 30, 2023 , there were 6,824,712 warrants outstanding at a weighted average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 9.13 years.

For the three and nine months ended September 30, 2023 and 2022, the Company recorded no income tax benefits for the net operating losses incurred or for the research and development tax credits generated in each period, due to its uncertainty of realizing a benefit from those items.

Substantially all of the Company’s operating losses since inception have been generated in the U.S.

4 unchanged sentences

compensation.

For both the three and six months ended June 30, 2023 , the Company contributed $ 0.1 million and $ 0.3 million, respectively, to the 401(k) Plan.

For the three and six months ended June 30, 2022 , the Company contributed $ 0.2 million and $ 0.4 million, respectively, to the 401(k) Plan.

For the three and nine months ended September 30, 2023 , the Company contributed $ 0.3 million and $ 0.6 million, respectively, to the 401(k) Plan.

For the three and nine months ended September 30, 2022 , the Company contributed $ 0.2 million and $ 0.6 million, respectively, to the 401(k) Plan.

Net Loss per Share

1 unchanged sentence

Three Months Ended

September 30,

Three Months Ended

Six Months Ended June 30,

September 30,

Nine Months Ended September 30,

Net loss attributable to common stockholders

3 unchanged sentences

The Company’s potential dilutive securities have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share.

Therefore, the weighted-average number of common shares outstanding used to calculate both

basic and diluted net loss per share attributable to common stockholders is the same.

Therefore, the weighted-average number of common shares outstanding used to calculate both basic and diluted net loss per share attributable to common stockholders is the same.

The Company excluded the following potential common shares, presented based on amounts outstanding at each period end, from the computation of diluted net loss per share attributable to common stockholders for the periods indicated, because including them would have had an anti-dilutive effect:

For the Six Months

Ended June 30,

For the Nine Months

Ended September 30,

Stock options to purchase common stock

2 unchanged sentences

Related Party Transactions

As of June 30, 2023 and December 31, 2022 , an aggregate of $ 0.2 million and $ 0.3 million, respectively, was due to Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement and the Adimab DNA Sequencing Services Agreement (as defined below) by the Company.

As of June 30, 2023 and December 31, 2022 , no amounts were due to the Company from Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement or the Adimab DNA Sequencing Services Agreement.

As of September 30, 2023 and December 31, 2022 , an aggregate of $ 5.8 million and $ 0.3 million, respectively, was due to Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement and the Adimab DNA Sequencing Services Agreement (as defined below) by the Company.

As of September 30, 2023 and December 31, 2022 , no amounts were due to the Company from Adimab under the Adimab Assignment Agreement, the Adimab Collaboration Agreement, the Adimab Platform Transfer Agreement or the Adimab DNA Sequencing Services Agreement.

Adimab Assignment Agreement

Under the Adimab Assignment Agreement, Adimab, a principal stockholder of the Company, is entitled to receive milestone and royalty payments upon specified conditions and receives payments from the Company for providing ongoing services under the agreement (see Note 7).

During the three and six months ended June 30, 2023, the Company recognized $ 0 and $ 0.4 million, respectively, as IPR&D expense with respect to a milestone payable under the Adimab Assignment Agreement.

During the three and six months ended June 30, 2023 , the Company did no t recognize any IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

During the three and six months ended June 30, 2022, the Company recognized $ 0.2 million and $ 0.5 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement.

During the three and nine months ended September 30, 2023, the Company recognized $ 3.2 million and $ 3.6 million, respectively, as IPR&D expense with respect to a milestone payable under the Adimab Assignment Agreement.

During the three and nine months ended September 30, 2023 , the Company did no t recognize any IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

During the three and nine months ended September 30, 2023 , the Company did no t recognize any research and development expense with respect to services performed by Adimab on the Company ’

s behalf under the Adimab Assignment Agreement.

During the three and nine months ended September 30, 2022, the Company recognized $ 0.1 million and $ 0.6 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Assignment Agreement.

Adimab Collaboration Agreement

Under the Adimab Collaboration Agreement, the Company is obligated to pay Adimab for certain fees, milestones and royalty payments (see Note 7).

During both the three and six months ended June 30, 2023 and 2022, the Company recognized $ 1.3 million and $ 2.6 million, respectively, of research and development expense related to the quarterly fee.

During the three and six months ended June 30, 2023 , the Company recognized $ 0.2 million and $ 0.4 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.

During both the three and nine months ended September 30, 2023 and 2022, the Company recognized $ 1.3 million and $ 3.9 million, respectively, of research and development expense related to the quarterly fee.

During the three and nine months ended September 30, 2023 , the Company recognized $ 0.1 million and $ 0.5 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.

During the three and nine months ended September 30, 2022, the Company recognized $ 0.3 million and $ 1.3 million, respectively, of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab Collaboration Agreement.

During both the three and nine months ended September 30, 2023 and 2022, the Company recognized $ 1.0 million of IPR&D expense related to an option exercise fee.

During both the three and nine months ended September 30, 2023, the Company recognized $ 0.2 million of IPR&D expense related to a drug delivery fee.

During the three and nine months ended September 30, 2022, the Company recognized $ 0 and $ 0.2 million, respectively, of research and development expense related to a drug delivery fee.

During both the three and nine months ended September 30, 2023, the Company recognized $ 0.2 million of IPR&D expense related to an optimization completion fee.

The Company did no t recognize any IPR&D expense related to an optimization completion fee during the three and nine months September 30, 2022.

Adimab Platform Transfer Agreement

Under the Adimab Platform Transfer Agreement, the Company is obligated to pay Adimab for certain fees, milestones and royalty payments (see Note 7).

During the three and six months ended June 30, 2023 , the Company did no t recognize any expense in connection with the Adimab Platform Transfer Agreement.

The Adimab Platform Transfer Agreement was not effective during the three and six months ended June 30, 2022.

During both the three and nine months ended September 30, 2023 , the Company recognized a portion of the first annual fee as research and development expense.

During both the three and nine months ended September 30, 2022, the Company recognized $ 3.0 million of IPR&D expense in connection with the upfront consideration payable for the rights assigned pursuant to the Adimab Platform Transfer Agreement.

Adimab DNA Sequencing Services Agreement

1 unchanged sentence

In exchange for the services performed, the Company will pay Adimab a fee for each yeast-derived DNA template sample present in the well within the sequencer plate.

During the three and six months ended June 30, 2023, the Company recognized less than $ 0.1 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab DNA Sequencing Services Agreement.

During the three and nine months ended September 30, 2023, the Company recognized less than $ 0.1 million of research and development expense with respect to services performed by Adimab on the Company’s behalf under the Adimab DNA Sequencing Services Agreement.

Mithril Group

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and Population Health Equity Partners III, L.P., which are collectively referred to as the Mithril Group, submitted a notice of intent to nominate three directors to the Company’s board of directors at the 2022 annual meeting of stockholders.

In April 2022, the Mithril Group filed definitive proxy materials with the SEC seeking election of three directors to the Company's board of directors and adoption of a non-binding resolution for director declassification.

In April 2022, the Mithril Group filed definitive proxy materials with the SEC seeking election of three directors to the Company’s board of directors and adoption of a non-binding resolution for director declassification.

Subsequently, during the year ended December 31, 2022, Mithril II LP requested that the Company reimburse it for costs associated with legal expenses, corporate governance matters and stockholder proposals incurred as a result of the aforementioned matters in connection with the Company’s 2022 annual meeting of stockholders.

The Company made such reimbursement payment to Mithril II LP in the amount of $ 1.4 million, which the Company recognized as a selling, general and administrative expense.

As of June 30, 2023 , no amounts were due to any member of the Mithril Group by the Company, and no amounts were due from any member of the Mithril Group to the Company.

As of September 30, 2023 , no amounts were due to any member of the Mithril Group by the Company, and no amounts were due from any member of the Mithril Group to the Company.

Population Health Partners, L.P.

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and Tamsin Berry, members of the Company’s board of directors, are Managing Partner and Partner of PHP, respectively.

During the three and six months ended June 30, 2023 , the Company recognized $ 0.8 million and $ 2.3 million, respectively, of research and development expense with respect to services performed by PHP in connection with the PHP Work Order, which terminated in accordance with its terms in May 2023.

The agreements with PHP were not effective during the three and six months ended June 30, 2022.

As of June 30, 2023 , no amounts were due to PHP by the Company, and no amounts were due from PHP to the Company.

During the three and nine months ended September 30, 2023 , the Company recognized $ 0 and $ 2.3 million, respectively, of research and development expense with respect to services performed by PHP in connection with the PHP Work Order, which terminated in accordance with its terms in May 2023.

The agreements with PHP were not effective during the three and nine months ended September 30, 2022.

As of September 30, 2023 , no amounts were due to PHP by the Company, and no amounts were due from PHP to the Company.

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

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These forward-looking statements include, without limitation, statements about the following:

the anticipated timing, design, progress and results of preclinical studies and clinical trials of our product candidates, including statements regarding initiation or completion of studies or trials and related preparatory work, the period during which results of any studies or trials will become available, and potential regulatory submissions, with respect to our VYD222 program and other research and development programs;

the design of VYD222 for broad neutralization activity against SARS-CoV-2 variants and the potential for neutralization activity against Omicron sublineages following XBB.1.5 and future SARS-CoV-2 variants;

our ability 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, and to generate 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;

the timing of any submission of filings for regulatory authorization or approval of, and our ability to obtain and maintain regulatory authorizations or approvals for, our product candidates;

our belief that the adintrevimab clinical data package has the potential to support accelerated development of VYD222;

our ability 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, and to generate a robust pipeline of product candidates which, if authorized or approved, could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and expanding into influenza and other high-need indications;

the anticipated timing of any submission of filings for regulatory authorization or approval of, and our ability to obtain and maintain regulatory authorizations or approvals for, our product candidates;

our belief that the adintrevimab clinical data package has the potential to support accelerated development of VYD222 in the U.S.;

the possibility for VYD222 and anticipated follow-on monoclonal antibody (“mAb”) candidates to follow a potential development pathway for mAbs using immunobridging via serum neutralizing titers and previously generated clinical trial data from a prototype antibody, and our plans to leverage this immunobridging pathway in the U.S.

to accelerate the clinical development of VYD222 and anticipated follow-on mAb candidates, with adintrevimab or future proprietary mAbs serving as the prototype;

our ability to produce additional candidates optimized to stay ahead of the evolving SARS-CoV-2 virus;

our plans to leverage our INVYMAB platform approach to produce additional mAb candidates optimized to stay ahead of the evolving SARS-CoV-2 virus;

our belief that a ‘serial monotherapy’

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our ability to leverage technology and our platform to identify and develop future product candidates;

our estimates of our expenses, ongoing losses, future revenue, capital requirements and our need for or ability to obtain additional funding before we can expect to generate any revenue from product sales, if any of our product candidates are authorized or approved;

our belief that we have sufficient cash resources to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2024;

our estimates of our expenses, ongoing losses, future potential revenue, capital requirements and our need for or ability to obtain additional funding before we can expect to generate any revenue from product sales, if any of our product candidates are authorized or approved;

our belief that we have sufficient cash resources to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q;

our competitive position and the development of and projections relating to our competitors or our industry;

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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.

Our 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.

We are 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.

Our proprietary INVYMAB platform approach combines state-of-the-art viral surveillance and predictive modeling with advanced antibody engineering.

Leveraging our INVYMAB platform approach, we are 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 June and July 2023, we announced positive initial data from an ongoing Phase 1 clinical trial of VYD222, a mAb candidate in development for the prevention of symptomatic COVID-19 in vulnerable populations, such as immunocompromised people.

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mAb is available, provided that the new mAb candidate:

(1) is similar to the prototype mAb such that it leverages a consistent manufacturing platform and has limited structural and functional differences, and (2) has supportive nonclinical data, such as favorable in vitro neutralization data against currently circulating SARS-CoV-2 variants.

(1) is similar to the prototype mAb such that it leverages a consistent manufacturing platform and has limited structural and functional differences;

and (2) has supportive nonclinical data, such as favorable in vitro neutralization data against currently circulating SARS-CoV-2 variants.

We plan to leverage this immunobridging pathway in the U.S.

to accelerate the clinical development of VYD222 and anticipated follow-on mAb candidates, with adintrevimab or future proprietary mAbs serving as the prototype.

In August 2023, we announced our plans to initiate a pivotal clinical trial of VYD222, referred to as the CANOPY trial, using a surrogate endpoint to generate the clinical data needed to enable a potential EUA submission for the prevention of symptomatic COVID-19.

We plan to enroll approximately 750 participants in the CANOPY trial across two cohorts in parallel.

For Cohort A, which is expected to enroll approximately 300 participants who are significantly immunocompromised, we plan to use serum neutralizing titers

against relevant SARS-CoV-2 variants at Day 28 as the primary efficacy endpoint.

The primary efficacy analysis will use an immunobridging approach comparing data obtained in the CANOPY trial for VYD222 to certain historical data from our previous Phase 2/3 clinical trial of adintrevimab for the prevention of symptomatic COVID-19 (EVADE), in which serum neutralizing titers correlated with observed clinical efficacy.

All Cohort A participants will receive VYD222 administered via IV infusion.

For Cohort B, which is expected to enroll approximately 450 participants at risk of exposure to SARS-CoV-2, the primary endpoint will be safety and tolerability.

In September 2023, we announced dosing of the first participant in a Phase 3 pivotal clinical trial of VYD222, referred to as the CANOPY clinical trial, which is designed to evaluate protection against symptomatic COVID-19 after receiving VYD222.

The safety, tolerability, pharmacokinetic profile, and immunogenicity of VYD222 will also be evaluated.

The CANOPY clinical trial is designed to rapidly generate the clinical data needed to enable a potential EUA submission for VYD222.

In November 2023, we announced the completion of enrollment in the CANOPY clinical trial, with approximately 750 participants enrolled in two cohorts (A and B) across multiple trial sites in the U.S.

In Cohort A, we enrolled approximately 300 participants who are significantly immunocompromised.

The primary efficacy analysis will use an immunobridging approach comparing data obtained in the CANOPY clinical trial for VYD222 to certain historical data from our previous Phase 2/3 clinical trial of adintrevimab for the prevention of symptomatic COVID-19, referred to as the EVADE clinical trial, in which serum neutralizing titers correlated with observed clinical efficacy.

All Cohort A participants received VYD222 administered via IV infusion.

In Cohort B, we enrolled approximately 450 participants at risk of exposure to SARS-CoV-2.

The primary endpoint for Cohort B will be safety and tolerability.

Secondary and exploratory endpoints will include serum neutralizing titers and clinical efficacy.

Cohort B participants will be randomized 2:1 to receive VYD222 or placebo administered via IV infusion.

We plan to initiate the CANOPY trial with a 4500 mg dose of VYD222.

We expect to have initial primary endpoint data from the CANOPY trial by approximately the end of 2023.

Cohort B participants were randomized 2:1 to receive VYD222 or placebo administered via IV infusion.

We initiated the CANOPY clinical trial with a 4500 mg dose of VYD222.

We expect to have initial primary endpoint data from the CANOPY clinical trial by late 2023 or early in the first quarter of 2024.

Given the urgent unmet medical need, we aim to submit an application for an EUA for VYD222 to the FDA as soon as practicable.

We are actively preparing for the potential commercial launch of VYD222 in the U.S.

in 2024, if authorized.

VYD222 is our second mAb candidate to enter clinical testing.

VYD222 was engineered from adintrevimab, our investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19.

We believe that the adintrevimab clinical data package has the potential to support accelerated development of VYD222.

Beyond VYD222, we plan to leverage our expanded laboratory capabilities and integrated discovery platform to produce additional candidates optimized to stay ahead of the evolving SARS-CoV-2 virus.

We have multiple anti-SARS-CoV-2 mAb candidates in the discovery/preclinical stage and recently nominated an additional candidate for further preclinical characterization.

We believe that the adintrevimab clinical data package has the potential to support accelerated development of VYD222 in the U.S.

Beyond VYD222, we plan to leverage our INVYMAB platform approach to produce additional mAb candidates optimized to stay ahead of the evolving SARS-CoV-2 virus.

We have multiple anti-SARS-CoV-2 mAb candidates in the discovery/preclinical stage.

In addition, we continue 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.

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Our ability to generate product revenue sufficient to achieve profitability will depend heavily on the successful development and eventual commercialization of one or more of our product candidates, if authorized or approved.

Since our inception, we have incurred significant losses, including a net loss of $85.5 million for the six months ended June 30, 2023.

As of June 30, 2023, we had an accumulated deficit of $619.0 million.

Since our inception, we have incurred significant losses, including a net loss of $125.0 million for the nine months ended September 30, 2023.

As of September 30, 2023, we had an accumulated deficit of $658.4 million.

We expect to continue to incur significant expenses and recognize losses in the foreseeable future as we expand and progress our research and development activities, as well as the associated manufacturing activities and commercialization efforts.

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seek regulatory authorization or approval for any product candidates that successfully complete clinical trials;

pursue marketing approvals or EUAs and reimbursement for our product candidates;

pursue reimbursement for our product candidates if regulatory authorization or approval is received;

acquire or in-license other product candidates, intellectual property and/or technologies;

further develop and validate our commercial-scale current Good Manufacturing Practices (“cGMP”) manufacturing process for VYD222;

manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and potential EUAs, regulatory approvals and commercial sales;

manufacture material under cGMP at our contracted manufacturing facilities for clinical trials and potential commercial sales;

maintain, expand, enforce, defend and protect our intellectual property portfolio;

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incur additional legal, accounting and other expenses in operating as a public company.

We do not anticipate generating revenue from product sales, including government supply contracts, unless and until we successfully complete clinical development and obtain marketing approvals or EUAs for one or more of our product candidates.

We would expect to explore a range of commercial go-to-market approaches, including building our own commercial organization, outsourcing to contract sales and marketing organizations, and/or partnering with other biopharmaceutical companies with established sales, marketing, and market access capabilities, in anticipation of potential EUA or marketing approval for any of our product candidates for the prevention and/or treatment of COVID-19.

Accordingly, if we obtain marketing approval or EUA for any of our product candidates, we will incur significant additional commercialization expenses related to product manufacturing, marketing, sales and distribution.

We do not anticipate generating revenue from product sales, including government supply contracts, unless and until we successfully complete clinical development and obtain regulatory approvals or EUAs for one or more of our product candidates.

We are exploring a range of commercial go-to-market approaches, including building our own commercial organization, outsourcing to contract sales and marketing organizations, and/or partnering with other biopharmaceutical companies with established sales, marketing, and market access capabilities, in anticipation of potential EUA or regulatory approval for any of our product candidates for the prevention and/or treatment of COVID-19.

Accordingly, if we obtain regulatory approval or EUA for any of our product candidates, we will incur significant additional commercialization expenses related to product manufacturing, marketing, sales and distribution.

As a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy.

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If we fail to raise capital or enter into such agreements as, and when, needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more of our product candidates or delay our pursuit of potential in-licenses or acquisitions.

Because of the numerous risks and uncertainties associated with pharmaceutical product development and emergence of SARS-CoV-2 VoCs, we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability.

Because of the numerous risks and uncertainties associated with pharmaceutical product development and emergence of SARS-CoV-2 variants of concern (“VoCs”), we are unable to accurately predict the timing or amount of increased expenses or when, or if, we will be able to achieve or maintain profitability.

We may never obtain regulatory authorization or approval for any of our product candidates.

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If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities of $298.4 million as of June 30, 2023, will be sufficient to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2024.

Based on our current operating plan, we believe that our existing cash, cash equivalents and marketable securities of $264.9 million as of September 30, 2023, will be sufficient to fund our operating expenses and capital expenditure requirements for at least 12

months from the issuance date of the interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q.

We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

See “Liquidity and Capital Resources.”

See the section entitled “Liquidity and Capital Resources”

for more information.

Impact of COVID-19 on Our Operations

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Non-refundable advance payments that we make for goods or 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.

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.

Our primary focus since inception has been the development of antibodies against COVID-19.

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Product candidates in later stages of clinical development generally have higher and more variable development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials.

Our research and development expenses could increase substantially in the near

term as we advance VYD222 through clinical development, pursue EUA or regulatory approval of our product candidates, continue to discover and develop additional product candidates and incur expenses associated with hiring additional personnel to support our research and development efforts, including the associated manufacturing activities.

Our research and development expenses could increase substantially in the near term as we advance VYD222 through clinical development, pursue EUA or regulatory approval of our product candidates, continue to discover and develop additional product candidates and incur expenses associated with hiring additional personnel to support our research and development efforts, including the associated manufacturing activities.

At this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the development of any of our product candidates.

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our ability to obtain and maintain patent, trademark and trade secret protection and regulatory exclusivity for our product candidates, if and when approved, and otherwise protecting our rights in our intellectual property portfolio;

our ability to maintain compliance with regulatory requirements, including current Good Clinical Practices (“cGCPs”), current Good Laboratory Practices (“cGLPs”) and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products;

receipt of timely marketing approvals from applicable regulatory authorities;

our ability to maintain compliance with regulatory requirements, including current Good Clinical Practices, current Good Laboratory Practices and cGMPs, and to comply effectively with other rules, regulations and procedures applicable to the development and sale of pharmaceutical products;

receipt of timely regulatory authorizations or approvals from applicable regulatory authorities;

potential significant and changing government regulation, regulatory guidance and requirements and evolving treatment guidelines;

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Acquired In-Process Research and Development Expenses

certain of Adimab’s platform patents and technology (the “IPR&D assets”) for use in the research and development of our product candidates.

Acquired in-process research and development (“IPR&D”) expenses consist primarily of costs of contingent milestone payments incurred to acquire rights to Adimab’s antibodies relating to COVID-19 and SARS and related intellectual property and a license to certain of Adimab’s platform patents and technology (the “IPR&D assets”) for use in the research and development of our product candidates.

We expensed the cost of the IPR&D assets because they had no alternative future use as of the acquisition date.

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Our selling, general and administrative expenses could increase in the future as our business expands and we increase our headcount to support the expected growth in our research and development activities and the potential commercialization of our product candidates.

In particular, we could incur additional commercialization expenses prior to any regulatory approval or EUA of our product candidates as we continue to expand our commercial function to support potential future product launches.

In particular, we expect to incur additional commercialization expenses prior to any regulatory approval or EUA of our product candidates as we continue to expand our commercial function to support potential future product launches.

We also anticipate that we will continue to incur increased expenses associated with operating as a public company, including increased costs of accounting, audit, legal, regulatory and tax-related services, director and officer insurance premiums, and investor and public relations costs.

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In June 2022, and subsequently amended in September 2022, we entered into a lease agreement for dedicated laboratory and office space in Newton, Massachusetts for research and development purposes.

Through June 30, 2023, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.

Through September 30, 2023, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.

We have not incurred material operating expenses for the rent, maintenance and insurance of facilities, or for the depreciation of fixed assets.

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Results of Operations

Comparison of the three months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended June 30, 2023 and 2022:

Comparison of the three months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the three months ended September 30, 2023 and 2022:

Three Months Ended

September 30,

Three Months Ended

September 30,

(in thousands)

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Three Months Ended

September 30,

Three Months Ended

September 30,

(in thousands)

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Total research and development expenses

Research and development expenses were $43.6 million for the three months ended June 30, 2023, compared to $37.1 million for the three months ended June 30, 2022.

The $6.5 million increase in research and development expenses was primarily due to the following:

The decrease in direct costs related to our adintrevimab program of $22.6 million was primarily due to a $7.3 million and a $13.0 million decrease in our contract manufacturing and contract research expenses, respectively, driven by expenses incurred for our adintrevimab clinical trials and manufacturing during the three months ended June 30, 2022, for which there was no comparable spend during the three months ended June 30, 2023.

In addition, other external and non-clinical expenses related to our adintrevimab program decreased by $2.3 million.

Research and development expenses were $25.6 million for the three months ended September 30, 2023, compared to $30.1 million for the three months ended September 30, 2022.

The $4.5 million decrease in research and development expenses was primarily due to the following:

The decrease in direct costs related to our adintrevimab program of $6.0 million was primarily due to a decrease in adintrevimab-related contract manufacturing and clinical trial costs after the nomination of our VYD222 product candidate in 2023.

The increase in direct costs related to our VYD222 program was due to the nomination of our VYD222 product candidate in 2023 to proceed to IND-enabling activities.

The costs were primarily related to contract manufacturing expenses for VYD222 commercial manufacturing.

Personnel-related costs, including salaries, bonuses, benefits and other compensation-related costs were $4.9 million and stock-based compensation expense was $1.6 million for the three months ended June 30, 2023, compared to personnel-related costs of $5.8 million and stock-based compensation expense of $3.4 million for the three months ended June 30, 2022.

The costs were primarily related to contract manufacturing costs for commercial manufacturing and clinical trial costs associated with dosing of our CANOPY clinical trial in September 2023.

In the first quarter of 2023, we prioritized the clinical development of VYD222 instead of NVD200, and therefore, there was no comparable spend for NVD200 during the three months ended September 30, 2023.

The decrease in personnel-related costs of $2.5 million was primarily due to a reduction in headcount, including a decrease in stock-based compensation expense of $2.2 million.

The increase in external discovery-related and other costs of $0.3 million was primarily due to an increase in contract manufacturing expenses related to our pipeline candidates of $0.6 million and an increase in other external costs of $0.5 million, partially offset by a decrease of $0.8 million related to the termination of a Research Collaboration and License Agreement with The Scripps Research Institute in 2022.

The increase in external discovery-related and other costs of $3.5 million was primarily due to an increase in contract manufacturing costs related to our pipeline candidates of $1.8 million and an increase in other external costs of $1.7 million.

Acquired In-Process Research and Development (“IPR&D”) Expenses

IPR&D expenses of $0.2 million for the three months ended June 30, 2023 consisted entirely of license fees due to WuXi Biologics under the Cell Line License Agreement.

There was no IPR&D expense recognized during the three months ended June 30, 2022.

IPR&D expenses of $4.6 million for the three months ended September 30, 2023, consisted of $3.2 million incurred related to a milestone under the Adimab Assignment Agreement and $1.4 million incurred related to an option exercise fee, a drug discovery fee and an optimization completion fee under the Adimab Collaboration Agreement.

IPR&D expenses of $4.0 million for the three months ended September 30, 2022 consisted of $1.0 million incurred related to an option exercise fee under the Adimab Collaboration Agreement and $3.0 million incurred related to our upfront consideration payable for the rights assigned under the Adimab Platform Transfer Agreement.

Selling, General and Administrative Expenses

Three Months Ended

September 30,

Three Months Ended

September 30,

(in thousands)

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Total selling, general and administrative expenses

Selling, general and administrative expenses were $10.1 million for the three months ended June 30, 2023, compared to $14.6 million for the three months ended June 30, 2022.

The $4.5 million decrease in selling, general and administrative expenses was primarily due to the following:

Personnel-related costs, including salaries, bonuses, benefits and other compensation-related costs were $2.4 million and stock-based compensation expense was $3.1 million for the three months ended June 30, 2023, compared to personnel-related costs of $2.8 million and stock-based compensation expense of $3.0 million for the three months ended June 30,

The decrease in personnel-related costs of $0.3 million was primarily due to a reduction in headcount for the three months ended June 30, 2023.

The decrease in professional and consultant fees of $3.9 million was primarily due to a $3.1 million decrease in legal fees incurred for the three months ended June 30, 2022, for which there was no comparable spend for the three months ended June 30, 2023, a decrease in director and officer insurance premiums of $0.5 million and a decrease in commercial costs of $0.3 million.

Other costs remained relatively consistent between periods.

Other income was $3.6 million for the three months ended June 30, 2023, consisting primarily of $1.6 million of interest earned on our invested cash balances and $2.0 million of net accretion of discounts related to our marketable securities.

Other income was $0.8 million for the three months ended June 30, 2022, consisting primarily of interest earned on invested cash balances.

Comparison of the six months ended June 30, 2023 and 2022

The following table summarizes our results of operations for the six months ended June 30, 2023 and 2022:

Six Months Ended June 30,

Selling, general and administrative expenses remained relatively consistent between periods.

Other income was $3.6 million for the three months ended September 30, 2023, consisting primarily of $1.9 million of interest earned on our invested cash balances and $1.7 million of net accretion of discounts related to our marketable securities.

Other income was $2.2 million for the three months ended September 30, 2022, consisting primarily of interest earned on invested cash balances.

Comparison of the nine months ended September 30, 2023 and 2022

The following table summarizes our results of operations for the nine months ended September 30, 2023 and 2022:

Nine Months Ended September 30,

(in thousands)

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Research and Development Expenses

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

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Total research and development expenses

Research and development expenses were $70.8 million for the six months ended June 30, 2023, compared to $129.2 million for the six months ended June 30, 2022.

Research and development expenses were $96.4 million for the nine months ended September 30, 2023, compared to $159.3 million for the nine months ended September 30, 2022.

The $62.9 million decrease in research and development expenses was primarily due to the following:

The decrease in direct costs related to our adintrevimab program of $97.6 million was primarily due to a $60.5 million and a $32.7 million decrease in our contract manufacturing and contract research expenses, respectively, driven by expenses incurred for our adintrevimab clinical trials and manufacturing during the six months ended June 30, 2022, for which there was no comparable spend during the six months ended June 30, 2023.

In addition, other external and non-clinical expenses related to our adintrevimab program decreased by $4.4 million.

The decrease in direct costs related to our adintrevimab program of $103.7 million was primarily due to a decrease in adintrevimab-related contract manufacturing and clinical trial costs after the nomination of our VYD222 product candidate in 2023.

The increase in direct costs related to our VYD222 program was due to the nomination of our VYD222 product candidate in 2023 to proceed to IND-enabling activities.

The costs were primarily related to contract manufacturing expenses for VYD222 commercial manufacturing.

Personnel-related costs, including salaries, bonuses, benefits and other compensation-related costs were $9.9 million and stock-based compensation expense was $3.9 million for the six months ended June 30, 2023, compared to personnel-related costs of $12.2 million and stock-based compensation expense of $6.5 million for the six months ended June 30, 2022.

The costs were primarily related to contract manufacturing costs for commercial manufacturing and clinical trial costs associated with dosing of our CANOPY clinical trial in September 2023.

In the first quarter of 2023, we prioritized the clinical development of VYD222 instead of NVD200 and therefore, there was no comparable spend for NVD200 during the nine months ended September 30, 2023.

The decrease in personnel-related costs of $7.4 million was primarily due to a reduction in headcount, including a decrease in stock-based compensation expense of $4.9 million.

The increase in external discovery-related and other costs of $3.8 million was primarily due to an increase in contract manufacturing expenses related to our pipeline candidates of $3.7 million and an increase in other external costs of $1.8 million, partially offset by a decrease in non-clinical and clinical trial costs of $1.7 million.

The increase in external discovery-related and other costs of $7.4 million was primarily due to an increase in contract manufacturing costs related to our pipeline candidates of $5.5 million and an increase in other external costs of $2.5 million, partially offset by a decrease in non-clinical and clinical trial costs of $0.6 million.

Acquired In-Process Research and Development (“IPR&D”) Expenses

IPR&D expenses of $1.0 million for the six months ended June 30, 2023 consisted of a $0.4 million milestone payment that became due to Adimab in March 2023 upon dosing of the first subject in a Phase 1 clinical trial evaluating VYD222 under the Adimab License Agreement and $0.6 million in license fees due to WuXi Biologics under the Cell Line License Agreement.

There was no IPR&D expense recognized during the six months ended June 30, 2022.

IPR&D expenses of $5.6 million for the nine months ended September 30, 2023, consisted of $3.6 million incurred related to milestones under the Adimab Assignment Agreement, $1.4 million incurred related to an option exercise fee, a drug discovery fee and an optimization completion fee under the Adimab Collaboration Agreement, and $0.6 million incurred related to license fees under the WuXi Biologics’

Cell Line License Agreement.

IPR&D expenses of $4.0 million for the nine months ended September 30, 2022, consisted of $1.0 million incurred related to an option exercise fee under to the Adimab Collaboration Agreement and $3.0 million incurred related to our upfront consideration payable for the rights under the Adimab Platform Transfer Agreement.

Selling, General and Administrative Expenses

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

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Total selling, general and administrative expenses

Selling, general and administrative expenses were $21.2 million for the six months ended June 30, 2023, compared to $23.3 million for the six months ended June 30, 2022.

Selling, general and administrative expenses were $34.0 million for the nine months ended September 30, 2023, compared to $36.5 million for the nine months ended September 30, 2022.

The $2.5 million decrease in selling, general and administrative expenses was primarily due to the following:

Personnel-related costs, including salaries, bonuses, benefits and other compensation-related costs were $5.6 million and stock-based compensation expense was $6.2 million for the six months ended June 30, 2023, compared to personnel-related costs of $5.6 million and a stock-based compensation credit of $1.8 million for the six months ended June 30, 2022.

The increase in personnel-related costs of $4.3 million was primarily due to the reversal of stock-based compensation expense related to the forfeiture of stock options in conjunction with the resignation of our former Chief Executive Officer and President during the six months ended June 30, 2022.

The decrease in professional and consultant fees of $6.4 million was primarily due to a $4.6 million decrease in legal fees incurred for the six months ended June 30, 2022, a decrease in director and officer insurance premiums of $1.0 million and a decrease in commercial costs of $0.8 million.

The increase in personnel-related costs of $4.5 million was primarily due to the reversal of stock-based compensation expense related to the forfeiture of stock options in conjunction with the resignation of our former Chief Executive Officer and President during the nine months ended September 30, 2022.

The decrease in professional and consultant fees of $6.9 million was primarily due to a $5.1 million decrease in legal fees incurred, a $1.6 million decrease in director and officer insurance premiums and a $0.2 million decrease in commercial costs for the nine months ended September 30, 2023.

Other costs remained relatively consistent between periods.

Other income was $7.4 million for the six months ended June 30, 2023, consisting primarily of $2.7 million of interest earned on our invested cash balances and $4.7 million of net accretion of discounts related to our marketable securities.

Other income was $0.8 million for the six months ended June 30, 2022, consisting primarily of interest earned on invested cash balances.

Other income was $11.0 million for the nine months ended September 30, 2023, consisting primarily of $4.6 million of interest earned on our invested cash balances and $6.4 million of net accretion of discounts related to our marketable securities.

Other income was $3.1 million for the nine months ended September 30, 2022, consisting primarily of interest earned on invested cash balances.

Liquidity and Capital Resources

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Since our inception in June 2020, we have not generated any revenue from any sources, including from product sales or government supply contracts, and have incurred significant operating losses and negative cash flows from operations.

We expect to incur substantial expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates.

We expect to incur substantial expenses and operating losses for the foreseeable future as we advance the clinical development of our product candidates and potentially commercialize such product candidates if we receive regulatory approval or EUA for such product candidates.

To date, we have financed our operations with net proceeds of $464.7 million from sales of our preferred stock, and with aggregate net proceeds from our IPO in August 2021 of $327.5 million.

As of June 30, 2023, we had cash, cash equivalents and marketable securities of $298.4 million.

As of September 30, 2023, we had cash, cash equivalents and marketable securities of $264.9 million.

The following table summarizes our sources and uses of cash for each of the periods presented:

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

Net cash used in operating activities

Net cash provided by investing activities

Net cash provided by (used in) investing activities

Net cash provided by financing activities

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Operating Activities

During the six months ended June 30, 2023, operating activities used $78.6 million of cash, primarily due to our net loss of $85.5 million, partially offset by non-cash charges of $6.5 million.

Net cash used in changes in our operating assets and liabilities consisted of a $6.6 million decrease in prepaid expenses and other current assets, partially offset by a $2.6 million increase in accounts payable, and a $5.3 million increase in accrued expenses.

The increase in accounts payable and accrued expenses was primarily due to the timing of vendor invoicing and payments.

The decrease in prepaid expenses and other current assets was primarily due to up-front payments related to our Phase 1 clinical trial for VYD222 and up-front payments to WuXi Biologics for manufacturing costs.

During the six months ended June 30, 2022, operating activities used $116.4 million of cash, primarily due to our net loss of $151.7 million, partially offset by non-cash charges of $8.8 million.

Net cash provided by changes in our operating assets and liabilities consisted of a $8.4 million increase in accounts payable, partially offset by a $18.8 million decrease in prepaid expenses and other current assets, a $3.7 million decrease in accrued expenses, and a $3.0 million decrease in other non-current assets.

During the nine months ended September 30, 2023, operating activities used $113.9 million of cash, primarily due to our net loss of $125.0 million, partially offset by non-cash charges of $9.6 million and changes in our operating assets and liabilities of $1.5 million.

The changes in our operating assets and liabilities primarily consisted of a $7.7 million increase in accounts payable and a $0.7 million increase in non-current liabilities, partially offset by a $5.5 million decrease in accrued expenses, a $1.2 million decrease in operating lease liabilities, and a $0.3 million increase in prepaid expenses and other current assets.

The increase in accounts payable and decrease in accrued expenses was primarily due to the timing of vendor invoicing and payments.

The decrease in prepaid expenses and other current assets and the decrease in other non-current assets was primarily due to our utilization of WuXi Biologics manufacturing deposits.

During the nine months ended September 30, 2022, operating activities used $172.6 million of cash, primarily due to our net loss of $196.7 million, partially offset by non-cash charges of $16.1 million and changes in our operating assets and liabilities of $8.1 million.

The changes in our operating assets and liabilities primarily consisted of a $22.4 million decrease in prepaid expenses and other current assets, a $10.4 million increase in accounts payable and a $3.1 million decrease in other non-current assets, partially offset by a $27.6 million decrease in accrued expenses, and a $0.2 million decrease in other current liabilities.

The increase in accounts payable and decrease in accrued expenses was primarily due to the timing of vendor invoicing and payments.

The decrease in prepaid expenses and other current assets and in other non-current assets was primarily due to our utilization of WuXi Biologics manufacturing deposits.

Investing Activities

Net cash provided by investing activities during the six months ended June 30, 2023 consisted of $199.4 million in maturities of marketable securities, offset by $91.2 million in purchases of investments and $0.6 million in purchases of property and equipment.

Net cash provided by investing activities during the six months ended June 30, 2022 primarily consisted of $49.0 million in maturities of marketable securities.

Net cash provided by investing activities during the nine months ended September 30, 2023 consisted of $294.6 million in maturities of marketable securities, offset by $91.2 million in purchases of marketable securities and $0.6 million in purchases of property and equipment.

Net cash used in investing activities during the nine months ended September 30, 2022 consisted of $140.3 million in purchases of marketable securities and $0.5 million in purchases of property and equipment, offset by $49.0 million in maturities of marketable securities.

Financing Activities

Net cash provided by financing activities during the six months ended June 30, 2023 consisted of $0.7 million from exercises of stock options and $0.1 million from issuance of common stock under the employee stock purchase plan.

Net cash provided by financing activities during the six months ended June 30, 2022 primarily consisted of $0.1 million from exercises of stock options.

Net cash provided by financing activities during the nine months ended September 30, 2023 primarily consisted of $0.7 million from exercises of stock options and $0.2 million from issuance of common stock under the employee stock purchase plan.

Net cash provided by financing activities during the nine months ended September 30, 2022 primarily consisted of $0.2 million from exercises of stock options and $0.1 million from issuance of common stock under the employee stock purchase plan.

Funding Requirements

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the timing and costs of securing sufficient capacity for clinical and commercial supply of our current and potential future product candidates, or the raw material components thereof;

the costs and timing of future commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval or EUA;

the costs and timing of commercialization activities, including product manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive regulatory approval or EUA;

the costs necessary to obtain regulatory approvals, if any, for products in the U.S.

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the effect of competing technological, product and market developments;

the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

the revenue, if any, received from commercial sales of our product candidates for which we receive regulatory authorization or approval;

the costs of operating as a public company;

the progression of the COVID-19 pandemic and emergence of potential outbreaks of other coronaviruses, including the impact of any business interruptions to our operations or to those of our contract manufacturers, suppliers or other vendors resulting from the COVID-19 pandemic or other similar public health crises.

We believe that our cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements into the fourth quarter of 2024.

We believe that our cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements for at least 12 months from the issuance date of the interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q.

We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our available capital resources sooner than we expect.

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To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences and anti-dilution protections that adversely affect your rights as a common stockholder.

Additional debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring debt, making acquisitions or capital expenditures or declaring dividends, which could adversely constrain our ability to conduct our business, and may require the issuance of warrants, which could potentially dilute your ownership interest.

business, and may require the issuance of warrants, which could potentially dilute your ownership interest.

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs, or product candidates or grant licenses on terms that may not be favorable to us.

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Contractual Obligations and Commitments

In June 2023, we committed to a noncancelable purchase obligation related to the procurement of resin for future use in VYD222 drug substance batches under the Amended and Restated Commercial Manufacturing Services Agreement with WuXi Biologics (the “Commercial Manufacturing Agreement”).

In June 2023, we committed to a noncancelable purchase obligation related to the procurement of resin for future use in VYD222 drug substance batches under a Commercial Manufacturing Services Agreement with WuXi Biologics, which was entered into in December 2020, amended and restated in August 2021 and further amended and restated in September 2023 (as amended and restated, the “Commercial Manufacturing Agreement”).

The total costs of contractually binding resin to be incurred by us is $10.4 million.

In July 2023, we committed to a noncancelable purchase obligation related to the procurement of materials to be used in VYD222 drug substance and drug product batches under the Commercial Manufacturing Agreement.

During the three months ended September 30, 2023, we committed to noncancelable purchase obligations related to the procurement of materials to be used in VYD222 drug substance and drug product batches under the Commercial Manufacturing Agreement.

The total costs of contractually binding materials to be incurred by us is $5.7 million.

In September 2023, we committed to a noncancelable purchase obligation related to commercial VYD222 drug substance batches under the Commercial Manufacturing Agreement.

The total costs of contractually binding commercial VYD222 drug substance batches to be incurred by us is $34.8 million.

For additional information, see Note 9 to our condensed consolidated financial statements appearing in this Quarterly Report on Form 10-Q.

Other than the above noted transactions, during the three and six months ended June 30, 2023, there were no material changes to our contractual obligations from those described in the 2022 Form 10-K.

Other than the above noted transactions, during the three and nine months ended September 30, 2023, there were no material changes to our contractual obligations from those described in the 2022 Form 10-K.

Critical Accounting Policies and Significant Judgments and Estimates

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The preparation of our financial statements and related disclosures requires us to make estimates, assumptions and judgments that affect the reported amount of assets, liabilities, revenue, costs and expenses, and related disclosures.

Our critical accounting policies and estimates

are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates”

Our critical accounting policies and estimates are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates”

in our 2022 Form 10-K.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 1. Financial Statements