What changed in this filing

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Item 1. Financial Statements

2025-05-15 compared with 2024-11-14 · 199 added, 356 removed, 441 unchanged (56% of the section changed)

3 unchanged sentences

(In thousands, except share and per share amounts)

September 30,

Current assets:

Cash and cash equivalents

Accounts receivable, net

Inventory, net

Accounts receivable

Prepaid expenses and other current assets

7 unchanged sentences

Accrued expenses (1)

Operating lease liabilities, current

Operating lease liabilities

Other current liability

Total current liabilities

Operating lease liabilities, non-current

Other non-current liability

Total liabilities

Commitments and contingencies (Note 9)

Stockholders’ equity (deficit):

Stockholders’ equity:

Preferred stock (undesignated), $ 0.0001 par value;

10,000,000 shares

authorized and no shares issued and outstanding at September 30, 2024

authorized and no shares issued and outstanding at March 31, 2025

and December 31, 2024

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1,000,000,000 shares authorized,

119,604,035 shares issued and outstanding at September 30, 2024;

119,961,445 shares issued and outstanding at March 31, 2025;

119,835,162 shares issued and outstanding at December 31, 2024

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Total liabilities, preferred stock and stockholders’ equity

(1) Includes related-party amounts of $ 1,349 and $ 700 as of September 30, 2024 and December 31, 2023, respectively (see Note 15) .

(1) Includes related-party amounts of $ 456 and $ 1,274 as of March 31, 2025 and December 31, 2024 , respectively (see Note 15).

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

2 unchanged sentences

(In thousands, except share and per share amounts)

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Product revenue, net

3 unchanged sentences

Research and development (2)

Acquired in-process research and development (3)

Selling, general and administrative

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Weighted-average common shares outstanding, basic and diluted

(1) Includes related-party amounts of $ 463 for both the three and nine months ended September 30, 2024 , and no related-party amounts for both the three and nine months ended September 30, 2023 (see Note 15) .

(2) Includes related-party amounts of $ 1,133 and $ 3,399 for the three and nine months ended September 30, 2024 , respectively, and related-party amounts of $ 1,448 and $ 6,666 for the three and nine months ended September 30, 2023, respectively (see Note 15).

(3) Includes no related-party amounts for both the three and nine months ended September 30, 2024 , and related-party amounts of $ 4,600 and $ 4,975 for the three and nine months ended September 30, 2023, respectively (see Note 15).

(1) Includes related-party amounts o f $ 452 for the three months ended March 31, 2025 and no related-party amounts for the three months ended March 31, 2024 (see Note 15) .

(2) Includes related-party amounts of $ 1,128 and $ 1,135 for the three months ended March 31, 2025 and 2024, respectively (see Note 15).

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

INVIVYD , INC.

CONDENSED CONSO LIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

CONDENSED CONSO LIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

(In thousands, except share amounts)

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Income (Loss)

Equity (Deficit)

Balances at December 31, 2024

Stock-based compensation expense

Issuance of common stock, net of

issuance costs

Issuance of common stock under the

employee stock purchase plan

Unrealized gain, net of tax

Balances at March 31, 2024

Stock-based compensation expense

Exercise of stock options

1 unchanged sentence

employee stock purchase plan

Balances at June 30, 2024

Stock-based compensation expense

Exercise of stock options

Issuance of common stock under the

employee stock purchase plan

Unrealized loss, net of tax

Balances at September 30, 2024

Balances at March 31, 2025

Treasury Stock

2 unchanged sentences

Income (Loss)

Equity (Deficit)

Balances at December 31, 2023

Vesting of restricted common stock

from early-exercised options

Exercise of stock options

Repurchase of unvested restricted

Retirement of treasury stock

Stock-based compensation expense

Issuance of common stock, net of

issuance costs

Issuance of common stock under the

employee stock purchase plan

Unrealized gain, net of tax

Unrealized gain on available-for-sale

securities, net of tax

Balances at March 31, 2024

Vesting of restricted common stock

from early-exercised options

Exercise of stock options

Repurchase of unvested restricted

Retirement of treasury stock

Stock-based compensation expense

Issuance of common stock under the

employee stock purchase plan

Unrealized gain, net of tax

Balances at June 30, 2023

Vesting of restricted common stock

from early-exercised options

Exercise of stock options

Repurchase of unvested restricted

Retirement of treasury stock

Stock-based compensation expense

Issuance of common stock under the

employee stock purchase plan

Unrealized gain, net of tax

Balances at September 30, 2023

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

2 unchanged sentences

(In thousands)

Nine Months Ended September 30,

Three Months Ended March 31,

Cash flows from operating activities:

1 unchanged sentence

Stock-based compensation expense

Net amortization of premiums and accretion of discounts on marketable securities

Amortization of operating lease right-of-use assets

Depreciation expense

Depreciation and amortization expense

Changes in operating assets and liabilities:

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Cash flows from investing activities:

Purchases of marketable securities

Maturities of marketable securities

Purchases of property and equipment

Net cash (used in) provided by investing activities

Net cash used in investing activities

Cash flows from financing activities:

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Payments for offering costs

Payments for repurchases of unvested restricted common stock

Net cash provided by financing activities

Net (decrease) increase in cash and cash equivalents

Effect of exchange rate changes on cash and cash equivalents

Net decrease in cash and cash equivalents

Cash and cash equivalents at beginning of period

1 unchanged sentence

Supplemental disclosure of cash flow information

Deferred offering costs in accrued expense

Deferred offering costs in accounts payable

Deferred offering costs in 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 devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2.

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

INVYMAB is designed to facilitate the rapid, serial generation of new monoclonal antibodies (“mAbs”) to address evolving viral threats.

(the “Company”) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2.

PEMGARDA (pemivibart) is the Company’s first monoclonal antibody (“mAb”) to receive regulatory authorization and was designed to keep pace with SARS-CoV-2 viral evolution.

On March 22, 2024, the Company received emergency use authorization (“EUA”) from the U.S.

Food and Drug Administration (“FDA”) for PEMGARDA (pemivibart) injection, for intravenous use, a half-life extended investigational mAb, for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

Food and Drug Administration (“FDA”) for PEMGARDA injection, for intravenous use, a half-life extended investigational mAb, for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.

In July 2024, the Company submitted a request to the FDA to amend the EUA for PEMGARDA, for the treatment of mild-to-moderate symptomatic COVID-19 in certain immunocompromised patients.

The submission utilizes a rapid immunobridging pathway previously aligned in principle with the FDA.

The EUA amendment request is based on positive immunobridging analyses of pemivibart versus comparator mAbs and data from the Company’s ongoing CANOPY Phase 3 clinical trial in participants with moderate-to-severe immune compromise.

The COVID-19 treatment EUA request focuses on the critical treatment needs of people in the U.S.

who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible.

PEMGARDA is the Company’s first mAb in a planned series of innovative mAb candidates designed to keep pace with SARS-CoV-2 viral evolution.

As the SARS-CoV-2 virus evolves over time, the Company anticipates leveraging its INVYMAB platform approach to periodically introduce new or engineered mAb candidates, an approach that would be analogous to the periodic updates made to influenza and COVID-19 vaccines.

In January 2024, the Company nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate, and in September 2024, the Company announced dosing of the first participants in a Phase 1 clinical trial of VYD2311.

VYD2311 is a mAb with high in vitro neutralization potency shown against prominent SARS-CoV-2 variants tested to date.

The Phase 1 randomized, blinded, placebo-controlled clinical trial will evaluate escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants.

The Phase 1 clinical trial is being conducted in Australia and will evaluate multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration.

The Company expects preliminary data readouts from the Phase 1 clinical trial late in the fourth quarter of 2024 and anticipates additional clinical readouts from the VYD2311 program throughout 2025.

The ongoing Phase 1 randomized, blinded, placebo-controlled clinical trial is evaluating escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants.

The Phase 1 clinical trial is being conducted in Australia and is evaluating multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration.

In February 2025, the Company announced completion of recruitment in its Phase 1 clinical trial of VYD2311, as well as positive clinical data for both safety and pharmacokinetics.

The Company expects additional data readouts from the Phase 1 clinical trial and VYD2311 program throughout 2025.

Like pemivibart, VYD2311 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.

In May 2024, the Company announced general alignment with the FDA on an expedient, repeatable immunobridging pathway to future potential EUAs for serial, novel mAbs for the prevention and treatment of symptomatic COVID-19.

This pathway provides the Company with the opportunity to rapidly, efficiently, and durably deliver high value medicines that prevent and treat symptomatic COVID-19 in vulnerable populations.

In addition to developing candidates for COVID-19, the Company expects to apply its INVYMAB platform approach to produce lead molecules for other viral diseases, such as influenza.

The Company was incorporated in the State of Delaware in June 2020.

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To date, the Company has received regulatory authorization for only one product candidate, PEMGARDA, which has not been approved, but has been authorized for emergency use by the FDA under an EUA, for pre-exposure prophylaxis of COVID-19 in certain adults and adolescent individuals (12 years of age and older weighing at least 40 kg).

Beyond VYD222 (pemivibart) and VYD2311, all of the Company’s other product candidates, other than adintrevimab, are currently in research development.

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

Beyond pemivibart and VYD2311, all of the Company’s other product candidates, other than adintrevimab, are currently in research development.

The Company has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles.

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

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

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The Company has primarily funded its operations with proceeds from sales of convertible preferred stock, proceeds from the Company’s initial public offering (“IPO”) and net proceeds received from shares of common stock sold under the Sales Agreement (as defined below).

In February 2024, the Company sold 9,000,000 shares of its common stock under the Sales Agreement at an average price of $ 4.50 per share for $ 39.3 million in net proceeds.

In February 2024,

the Company sold 9,000,000 shares of its common stock under the Sales Agreement at an average price of $ 4.50 per share for $ 39.3 million in net proceeds.

After receiving EUA in March 2024, the Company has also funded its operations from sales of PEMGARDA.

The Company has incurred losses and negative cash flows from operations since its inception, including a net loss of $ 151.5 million for the nine months ended September 30, 2024.

As of September 30, 2024, the Company had an accumulated deficit of $ 883.6 million.

The Company has incurred recurring losses and negative cash flows from operations since its inception, including a net loss of $ 16.3 million for the three months ended March 31, 2025.

As of March 31, 2025, the Company had an accumulated deficit of $ 918.3 million.

The Company may continue to generate operating losses for the foreseeable future.

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Basis of Presentation

The Company’s condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S.

The accompanying condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S.

Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S.

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Unaudited Interim Financial Information

The accompanying condensed consolidated balance sheet as of September 30, 2024, the condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2024 and 2023, the condensed consolidated statements of cash flows for the three and nine months ended September 30, 2024 and 2023 and the condensed consolidated statements of stockholders’ equity (deficit) for the three and nine months ended September 30, 2024 and 2023 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of September 30, 2024 and for the three and nine months ended September 30, 2024 and 2023, 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 March 31, 2025, the condensed consolidated statements of operations and comprehensive loss for the three months ended March 31, 2025 and 2024, the condensed consolidated statements of cash flows for the three months ended March 31, 2025 and 2024 and the condensed consolidated statements of stockholders’ equity for the three months ended March 31, 2025 and 2024 are unaudited.

The accompanying unaudited condensed consolidated financial statements as of March 31, 2025 and for the three months ended March 31, 2025 and 2024 have been prepared by the Company pursuant to the rules and regulations of the U.S.

Securities and Exchange Commission (“SEC”) for interim financial statements.

The accompanying condensed consolidated balance sheet as of December 31, 2024 was derived from audited financial statements, but does not include all disclosures required by U.S.

Certain information and footnote disclosures

normally included in the financial statements prepared in accordance with U.S.

Certain information and footnote disclosures normally included in the financial statements prepared in accordance with U.S.

GAAP have been condensed or omitted pursuant to such rules and regulations.

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, 2024 and December 31, 2023, the condensed consolidated results of operations for the three and nine months ended September 30, 2024 and 2023, the condensed consolidated cash flows for the three and nine months ended September 30, 2024 and 2023, and changes in stockholders’ equity (deficit) for the three and nine months ended September 30, 2024 and 2023 have been made.

The Company’s condensed consolidated results of operations for the three and nine months ended September 30, 2024 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2024 .

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, 2024, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 20, 2025 (the “2024 Form 10-K”).

In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s condensed consolidated financial position as of March 31, 2025 and December 31, 2024, the condensed consolidated results of operations for the three months ended March 31, 2025 and 2024, the condensed consolidated cash flows for the three months ended March 31, 2025 and 2024, and changes in stockholders’ equity for the three months ended March 31, 2025 and 2024 have been made.

The Company’s condensed consolidated results of operations for the three months ended March 31, 2025 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2025 .

Summary of Significant Accounting Policies

As of September 30, 2024, 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, 2023, as filed with the U.S.

Securities and Exchange Commission (“SEC”) on March 28, 2024 (the “2023 Form 10-K”) have not changed, except as discussed below.

Prior to receiving regulatory approval or authorization, costs related to the manufacturing of inventory are recorded as research and development expense on the Company’s consolidated statements of operations and comprehensive loss in the period incurred.

In connection with the EUA for PEMGARDA in March 2024, the Company subsequently began capitalizing PEMGARDA inventory costs as it was determined that inventory costs incurred subsequent to the EUA had a probable future economic benefit.

Inventory is stated at the lower of cost or estimated net realizable value with cost determined on a first-in, first-out basis.

Inventory costs include raw materials, third-party contract manufacturing, third-party packaging services, freight and overhead.

The Company reduces its inventory to net realizable value for potentially excess, dated or obsolete inventory based on a quarterly assessment of the recoverability of its capitalized inventory.

The Company periodically reviews inventory levels to identify what may expire prior to expected sale or has a cost basis in excess of its estimated realizable value and writes-down such inventories as appropriate as a component of costs of goods sold in the consolidated statements of operations and comprehensive loss .

Concentrations of Credit Risk, Significant Suppliers and License Rights

Financial instruments that potentially expose the Company to concentrations of credit risk consist of cash, cash equivalents and accounts receivable.

As of September 30, 2024, the Company invested its excess cash in money market funds that are subject to minimal credit and market risks.

The Company maintains its existing cash and cash equivalents at three accredited financial institutions.

From time to time, these deposits may exceed federally insured limits.

The Company has not experienced any losses historically in these accounts.

Accordingly, the Company does not believe it is exposed to unusual credit risk related to its existing cash and cash equivalents beyond the normal credit risk associated with commercial banking relationships.

As of September 30, 2024, the Company's net product revenue was generated from sales to the Title Company (as defined below) and three third-party specialty distributors (see “Revenue Recognition” for additional information).

The Company is dependent on third-party organizations to manufacture and process its product candidates for its research and development programs.

In particular, the Company relies on a single third-party contract manufacturer to produce and process its product candidates and to manufacture supply of its product candidates for preclinical and clinical activities.

The Company also currently relies on this same third-party contract manufacturer for any anticipated requirements of commercial supply, including both drug substance and drug product (see Note 9).

The Company expects to continue to be dependent on a small number of third-party organizations to supply it with its requirements for all product candidates.

The Company’s research and development programs, including any associated commercialization efforts, could be adversely affected by a significant interruption in the supply of the necessary materials.

The Company is dependent on a limited number of third parties that provide license rights used by the Company in the development and commercialization of its product candidates and programs.

Through September 30, 2024 , the Company’s research and development programs primarily relate to rights conveyed by Adimab (see Note 7).

The Company could experience delays in the development and commercialization of its product candidates and programs if the Adimab agreements or any other license agreement utilized in the Company’s research and development activities is terminated, if the Company fails to meet the obligations required under its arrangements, or if the Company is unable to successfully secure new strategic alliances or licensing agreements.

Accounts Receivable

Accounts receivable as of September 30, 2024 is comprised of $ 8.2 million of PEMGARDA product sales to the Title Company (as defined below) and three third-party specialty distributors (see “Revenue Recognition” for additional information).

Revenue Recognition

The Company recognizes revenue in accordance with ASC Topic 606 - Revenue from Contracts with Customers (“ASC 606”).

Under ASC 606, an entity recognizes revenue when or as performance obligations are satisfied by transferring control of promised goods or services to the customer, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.

To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps:

(i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation.

At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Product Revenue, Net

Following EUA from the FDA in March 2024, the Company began generating product revenue from sales of PEMGARDA in April 2024.

The Company entered into a third-party logistics distribution agreement (the “3PL Agreement”) to engage a logistics distribution agent (the “3PL Agent”) to distribute the Company’s products to its customers.

The 3PL Agent provides services to the Company that include storage, distribution, processing product returns, customer service support, logistics support, electronic data interface and system access support.

Revenue is recognized when or as performance obligations are satisfied by transferring control of promised goods to a customer, generally upon delivery, based on an amount that reflects the consideration to which the Company expected to be entitled.

To date, the Company applied for mandatory distribution licenses that some states require for the Company to sell its product throughout the U.S.

In order for the Company to execute sales in the U.S.

prior to obtaining such licenses, the Company and an affiliate of the 3PL Agent (the “Title Company”) entered into a Temporary Title Model Agreement (the “Temporary Title Model Agreement”), which was an amendment to the 3PL Agreement, so that the Title Company could purchase and take title to the product and sell the product to the specialty distributors who contracted to purchase the product from the Company.

Although under the Temporary Title Model Agreement, the Title Company took title to the product, the economic substance of the transaction provided that the Title Company did not possess the risk of loss or participate in the significant risks and rewards of ownership of the product or have the ability to control, direct the use of, and obtain substantially all of the remaining benefits from the product.

Accordingly, the Company did not recognize revenue upon the transfer of the goods at the time of sale to the Title Company and recognized revenue when the goods were sold from the Title Company to the specialty distributors.

In July 2024, the Company obtained nearly all of the necessary state distribution licenses to sell its products throughout the U.S.

and ceased using the Temporary Title Model Agreement process in the third quarter of 2024.

Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.

Discounts and Allowances

The Company records reserves, based on contractual terms, for the following components of variable consideration related to product sold during the reporting period, as well as its estimate of product that remains in the distribution channel inventory of its customers at the end of the reporting period, if applicable.

On a quarterly basis, the Company updates its estimates, if necessary, and records any material adjustments in the period they are identified.

Trade Discounts and Distributor Fees

The Company provides customary discounts on PEMGARDA sales for prompt payment, the terms of which are explicitly stated in its contracts.

The Company also pays fees to specialty distributors for sales order management, data, and distribution services, the terms of which are also explicitly stated in its contracts.

Such fees are not for a distinct good or service and, accordingly, are recorded as a reduction of revenue, as well as a reduction to accounts receivable (trade discounts) or as a component of accrued expenses (distributor fees).

Government Chargebacks and Rebates

The Company is subject to discount obligations under its contract with the U.S.

Department of Veterans Affairs.

These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included as a component of accrued expenses.

Product Returns

The Company offers a right of return for purchased units of PEMGARDA for damage, defect, recall, and/or product expiry, provided the product expiry is within a specified period as set forth in the Company’s return goods policy.

The Company estimates the

amount of product sales that will be returned using quantitative and qualitative considerations.

Reserves for estimated returns are recorded as a reduction of product revenue in the period that the related revenue is recognized, as well as a component of accrued expenses.

Other Incentives

Other incentives include a co-pay assistance program for eligible patients with commercial insurance in the U.S.

The co-pay assistance program assists certain commercially insured patients by reducing each participating patient’s financial responsibility for the purchase price, up to a specified dollar amount of assistance.

As of March 31, 2025, the Company’s significant accounting policies and estimates, which are detailed in the Company’s 2024 Form 10-K, have not materially changed.

Use of Estimates

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Actual results may differ materially from those estimates or assumptions.

Recently Issued and Adopted Accounting Pronouncements

Recently Issued Accounting Pronouncements

The Company is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and may remain an emerging growth company until the last day of the fiscal year following the fifth anniversary of the completion of its IPO.

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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.

In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280):

Improvements to Reportable Segment Disclosures (“ASU 2023-07”).

ASU 2023-07 requires disclosure of incremental segment information on an annual and interim basis.

The amendments also require companies with a single reportable segment to provide all disclosures required by this amendment and all existing segment disclosures in ASC 280, Segment Reporting.

The amendments are effective for fiscal years beginning after December 15, 2023, and interim periods beginning after December 15, 2024.

The Company is currently evaluating the potential impacts of ASU 2023-07 on its consolidated financial statement disclosures.

In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740):

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The Company is currently evaluating the potential impacts of ASU 2023-09 on its consolidated financial statement disclosures.

In November 2024, the FASB issued ASU 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40):

Disaggregation of Income Statement Expenses (“ASU 2024-03 ”).

The new standard requires additional disclosure of the nature of expenses included in the income statement as well as disclosures about specific types of expenses included in the expense captions presented in the income statement.

ASU 2024-03 is effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027.

The Company is currently evaluating the potential impact of ASU 2024-03 on its consolidated financial statement disclosures.

Fair Value Measurements

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Fair Value Measurements at

September 30, 2024:

March 31, 2025:

Cash equivalents:

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The money market funds were valued by the Company based on quoted market prices, which represent a Level 1 measurement within the fair value hierarchy.

There were no changes to the valuation methods during the three and nine months ended September 30, 2024 or 2023.

There were no changes to the valuation methods during the three months ended March 31, 2025 or 2024.

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 nine months ended September 30, 2024 or 2023.

The following table presents inventories (in thousands):

September 30,

There were no transfers into or out of Level 1, Level 2 or Level 3 fair value measurements during the three months ended March 31, 2025 or 2024 .

The following table presents non-current inventories (in thousands):

Work in process

Finished goods

The Company did no t have any inventory as of December 31, 2023.

As of March 31, 2025, $ 0.4 million of finished goods inventory was classified as a current asset and included within prepaid and other current assets in the condensed consolidated balance sheet.

Please refer to Note 5 for additional information.

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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Interest receivable

Finished goods inventory, current

Accrued Expenses

Accrued expenses consisted of the following (in thousands):

September 30,

Accrued external research, development and manufacturing costs

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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 nine months ended September 30, 2024 and 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 months ended March 31, 2025 and 2024 , 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.

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 a total of $ 11.1 million has been achieved and paid as of September 30, 2024;

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, which was paid in May 2023.

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.

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 pemivibart, which obligated the Company to make a $ 0.4 million milestone payment to Adimab, which was paid in May 2023.

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 pemivibart, which obligated the Company to make a $ 3.2 million milestone payment to Adimab, which was paid in October 2023.

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, 2024.

During both the three and nine months ended September 30, 2024, the Company did no t recognize any 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, 2023, the Company recognized $ 3.2 and $ 3.6 million, respectively, of IPR&D expense

with respect to contingent consideration payable under the Adimab Assignment Agreement.

Except for milestone payments of $ 11.1 million incurred through December 31, 2023, no other milestone payments have been paid to or have been earned by Adimab through September 30, 2024.

GAAP and therefore, no expense was recognized as of March 31, 2025.

During the three months ended March 31, 2025 and 2024, the Company did no t recognize any in-process research and development (“IPR&D”) expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

for milestone payments of $ 11.1 million incurred through December 31, 2023, no other milestone payments have been paid to or have been earned by Adimab through March 31, 2025.

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.

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Royalties are due on a Product-by-Product and country-by-country basis beginning upon the first commercial sale of each Product and ending on 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 patent covering such Product in such country (the “Royalty Term”).

During both the three and nine months ended September 30, 2024 , the Company expensed $ 0.5 million of royalties and reserves all rights under the Adimab Assignment Agreement and the applicable law.

During both the three and nine months ended September 30, 2023 , the Company did no t expense any royalties.

During the three months ended March 31, 2025, the Company expensed $ 0.5 million of royalties, while reserving all rights under the Adimab Assignment Agreement and the applicable law.

During the three months ended March 31, 2024 , the Company did no t expense any royalties.

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.

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Effective January 2024, the Company became obligated to pay Adimab a quarterly fee of $ 0.6 million.

During the three and nine months ended September 30, 2024 , the Company recognized $ 0.6 million and $ 1.8 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 both the three months ended March 31, 2025 and 2024 , the Company recognized $ 0.6 million 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 both the three and nine months ended

September 30, 2024, 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 Collaboration Agreement.

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, 2024, the Company did no t recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees.

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 months ended March 31, 2025 and 2024, 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 Collaboration Agreement.

During both the three months ended March 31, 2025 and 2024, the

Company did no t recognize any IPR&D expense related to drug delivery fees, optimization completion fees or option exercise fees.

Please refer to Note 15 for additional information.

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

GAAP and therefore, no expense was recognized as of September 30, 2024.

GAAP and therefore, no expense was recognized as of March 31, 2025.

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 September 30, 2024, no royalty payments have been paid to or have been earned by Adimab under the Adimab Collaboration Agreement.

Through March 31, 2025, no royalty payments have been paid to or have been earned by 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 first annual fee became due in September 2023 and was paid in October 2023.

During the three and nine months ended September 30, 2024, the Company recognized a portion of the annual fees as research and development expense.

During both the three months ended March 31, 2025 and 2024 , the Company recognized $ 0.5 million of research and development expense related to the annual fees.

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.

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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, 2024.

GAAP and therefore, no expense was recognized as of March 31, 2025.

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, subject to reductions specified under the Adimab Platform Transfer Agreement.

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 September 30, 2024, no royalty payments have been paid to or have been earned by Adimab under the Adimab Platform Transfer Agreement.

in such product in such country.

Through March 31, 2025, no royalty payments have been paid to or have been earned by 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.

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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 September 30, 2024 , no royalties had become due to WuXi Biologics.

Through March 31, 2025 , no royalties had become due to WuXi Biologics.

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

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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.

The Company did no t recognize any IPR&D expense under the Cell Line License Agreement during the three and nine months ended September 30, 2024 .

The Company recognized $ 0 and $ 0.6 million of IPR&D expense under the Cell Line License Agreement during the three and nine months ended September 30, 2023 , respectively.

The Company did no t recognize any IPR&D expense under the Cell Line License Agreement during both the three months ended March 31, 2025 and 2024 .

Population Health Partners, L.P.

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The PHP MSA was terminated effective in July 2024.

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.

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.

The PHP Work Order was effective for six months from the PHP Effective Date and terminated in accordance with its terms in May 2023.

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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 nine months ended September 30, 2024 , the Company did no t recognize any 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.

During both the three months ended March 31, 2025 and 2024 , the Company did no t pay any cash compensation to PHP and therefore did not recognize any research and development expense related thereto.

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”).

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In September 2021, the Company entered into a five-year noncancelable facilities lease agreement for approximately 9,600 square feet of office space in Waltham, Massachusetts, which provides for monthly rental payments, including base rent charges of $ 0.4 million per year, subject to periodic rent increases, and the Company’s proportionate share of operating expenses.

This lease agreement is scheduled to expire on May 31, 2025.

In June 2022, the Company entered into a two-year noncancelable agreement for dedicated laboratory and office space in Newton, Massachusetts (the “Newton, MA Lease”), which was amended in September 2022.

Pursuant to the amended Newton, MA Lease, the

Company entered into a two-year noncancelable agreement for new dedicated laboratory and office space in Newton, Massachusetts, on the same campus as, and in lieu of, the space leased under the original lease.

Pursuant to the amended Newton, MA Lease, the Company entered into a two-year noncancelable agreement for new dedicated laboratory and office space in Newton, Massachusetts, on the same campus as, and in lieu of, the space leased under the original lease.

The Company took occupancy of the new dedicated laboratory and office space in December 2022.

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For the Three Months

Ended September 30,

Ended March 31,

For the Three Months

Ended September 30,

For the Nine Months

Ended September 30,

For The Nine Months

Ended September 30,

Ended March 31,

Operating lease cost

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Operating cash flows related to operating leases

Future minimum lease payments under the noncancelable leases as of September 30, 2024 was as follows (in thousands):

Future minimum lease payments under the noncancelable leases as of March 31, 2025 was as follows (in thousands):

Year Ending December 31,

Operating Lease

2024 (excluding the nine months ended September 30, 2024)

2025 (excluding the three months ended March 31, 2025)

Total lease payments

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Present value of operating lease liability

As of September 30, 2024 , 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 1.1 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 March 31, 2025 , 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 0.6 years.

As of March 31, 2024 , 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 1.7 years.

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

$ 1.4 million is classified under “ operating lease liabilities, current” for the portion due within twelve months, and $ 0.2 million is classified under “operating lease liabilities, non-current”.

$ 0.9 million is classified under “operating lease liabilities, current” for the portion due within twelve months.

There was no operating lease liability classified under “operating lease liabilities, non-current”.

License Agreements

The Company has entered into license agreements with Adimab and WuXi Biologics (see Note 7).

Other Agreements

In November 2022, the Company entered into the PHP MSA (see Note 8).

Concurrently with the PHP MSA, the Company entered into the PHP Work Order, pursuant to which PHP agreed to advise and counsel the Company regarding clinical development and regulatory matters with respect to its product candidates.

The PHP Work Order was effective for six months from November 2022 and terminated in accordance with its terms in May 2023.

As compensation for the services and deliverables under the PHP Work Order, the Company recognized research and development expense of $ 0.5 million per month during the term of the PHP Work Order for an Aggregate Fee of $ 3.0 million.

Manufacturing Agreements

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

Through September 30, 2024, the Company committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.

As of September 30, 2024 , the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $ 38.3 million, which is expected to be paid in 2024 and 2025.

As of September 30, 2024 , $ 36.5 million related to the contractually binding commercial drug substance and drug product batches was included in accounts payable and accrued expenses, which is expected to be paid in 2024 and 2025.

Through September 30, 2024, the Company committed to noncancelable purchase obligations related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.

As of September 30, 2024 , the total remaining contractually binding purchase obligations due to WuXi Biologics was $ 17.0 million, which is expected to be paid in 2024 and 2025.

As of September 30, 2024 , $ 10.6 million related to the procurement of materials to be used in future drug substance and drug product manufacturing was included in accounts payable and accrued expenses, which is expected to be paid in 2024 and 2025.

Through March 31, 2025, the Company committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.

As of March 31, 2025 , the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $ 27.4 million, which is expected to be paid in 2025.

As of March 31, 2025, the total remaining purchase obligation, related to the contractually binding commercial drug substance and drug product batches, was included in accounts payable and accrued expenses, which is expected to be paid in 2025.

Through March 31, 2025, the Company committed to noncancelable purchase obligations related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.

As of March 31, 2025 , the total remaining contractually binding purchase obligations due to WuXi Biologics was $ 6.3 million, which is expected to be paid in 2025.

As of March 31, 2025, the total remaining purchase obligation, related to the procurement of materials to be used in future drug substance and drug product manufacturing, was included in accounts payable and accrued expenses, which is expected to be paid in 2025.

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.

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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 timely cured after notice thereof.

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 timely cured after notice thereof.

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.

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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 September 30, 2024 and December 31, 2023.

The termination fees were not probable of payment as of March 31, 2025 and December 31, 2024.

Legal Proceedings

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Legal fees and other costs associated with such proceedings are expensed as incurred.

On January 31, 2023, a securities class action lawsuit captioned Brill v.

Invivyd, Inc., et.

al., Case No.

1:23-CV-10254-LTS, was filed against the Company and certain of its former officers in the U.S.

District Court for the District of Massachusetts.

The complaint alleged violations of Sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated thereunder on the basis of purportedly materially false and misleading statements and omissions concerning ADG20’s effectiveness against the Omicron variant of COVID-19.

The complaint sought, among other things, unspecified damages, attorneys’ fees, expert fees, and other costs.

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

On August 23, 2023, the lead plaintiffs filed an amended complaint that made allegations similar to those in the original complaint and asserted 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 intended to seek leave to file a second amended complaint, and on November 22, 2023, the lead plaintiffs filed a second amended complaint that made allegations similar to those in the prior complaints and asserted the same claims against the same defendants as the prior complaints.

On January 12, 2024, the defendants filed a motion to dismiss the second amended complaint in its entirety.

The lead plaintiffs filed an opposition to the motion to dismiss on February 26, 2024, and the defendants filed a reply in further support of their motion to dismiss on March 27, 2024.

The court heard oral arguments on the defendants’ motion to dismiss on May 10, 2024.

The court granted the defendants’ motion to dismiss on September 18, 2024, dismissing the second amended complaint in its entirety, with prejudice and without leave to amend.

The plaintiffs did not appeal the court's decision.

As such, the Company has concluded that this matter is closed.

As of March 31, 2025, the Company was not a party to any material legal proceedings.

Indemnification Agreements

with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties.

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to its vendors, lessors, contract research organizations, contract development and manufacturing organizations (“CDMOs”), business partners and other parties with respect to certain matters, including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties.

In addition, the Company has entered into indemnification agreements with members of its board of directors and its executive officers that require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or executive officers.

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Shares Reserved for Future Issuance

As of September 30, 2024 , the Company had reserved 45,909,485 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 March 31, 2025 , the Company had reserved 37,552,075 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

In September 2022, the Company filed a shelf registration statement on Form S-3 with the SEC (File No.

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, 2024 , $ 325 million of the Company’s securities remained available for offer and sale under this shelf registration statement.

In September 2022, the Company filed a shelf registration statement on Form S-3 with the SEC 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 March 31, 2025 , $ 325 million of the Company’s securities remained available for offer and sale under this shelf registration statement.

In December 2023, the Company entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cant or Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which the Company may, at its option, offer and sell shares of its common stock, with a sales value of up to $ 75.0 million, from time to time, through Cantor, acting as sales agent, in transactions deemed to be “at the market offerings”, as defined in Rule 415 under the Securities Act of 1933, as amended.

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In February 2024, the Company sold 9,000,000 shares of its common stock under the Sales Agreement at an average price of $ 4.50 per share for $ 39.3 million in net proceeds.

As of September 30, 2024 , $ 34.5 million remained available for sale under the Sales Agreement.

Treasury Stock

In March 2023, the Company repurchased, and subsequently retired, 206,802 shares of unvested restricted common stock at the original purchase price upon a termination of service of an employee during the vesting period.

The fair value of the repurchased common stock was insignificant.

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

In May 2023, the Company repurchased 46,600 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.

The fair value of the repurchased common stock was insignificant.

In June 2023, the Company retired the 46,600 shares of treasury stock.

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

In October 2023, the Company repurchased 31,765 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.

The fair value of the repurchased common stock was insignificant.

In December 2023, the Company retired the 31,765 shares of treasury stock.

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

As of March 31, 2025 , $ 34.5 million remained available for sale under the Sales Agreement.

Stock-Based Compensation

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The exercise price for stock options granted may not be less than the fair market value of the Company’s common stock on the date of grant, as determined by the board of directors, or at least 110 % of the fair market value of the Company’s common stock on the date of grant in the case of an incentive stock option granted to an employee who owns stock representing more than 10 % of the voting power of all classes of stock as determined by the board of directors as of the date of grant.

Prior to the IPO, the Company’s board of directors determined the fair value of the Company’s common stock, taking into consideration its most recently available valuation of

common stock performed by third parties as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant.

Prior to the IPO, the Company’s board of directors determined the fair value of the Company’s common stock, taking into consideration its most recently available valuation of common stock performed by third parties as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant.

Stock options granted under the 2020 Plan expire after ten years and typically vest over a four-year period with the first 25 % vesting upon the first anniversary of a specified vesting commencement date and the remainder vesting in 36 equal monthly installments over the succeeding three years , contingent on the recipient’s continued employment or service.

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 September 30, 2024, there were 2,985,456 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 March 31, 2025 , there were 1,036,823 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

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plus the number of shares (not to exceed 23,661,550 shares), which represents (i) the number of shares that remained available for issuance under the 2020 Plan, at the time the 2021 Plan became effective, and (ii) any shares subject to outstanding stock options or other stock awards that were granted under the 2020 Plan that are forfeited, terminate, expire or are otherwise not issued.

In December 2024, the 2021 Plan was amended by Amendment No.

1 to the 2021 Plan, which decreased the aggregate number of shares of the Company’s common stock reserved for issuance under the 2021 Plan by 8,000,000 shares.

In addition, the number of shares of the Company’s common stock reserved for issuance under the 2021 Plan will automatically increase on the first day of each calendar year pursuant to the evergreen provision thereof , beginning on January 1, 2022 and continuing through January 1, 2031, in an amount equal to 5 % of the shares of common stock outstanding on the last day of the calendar month before the date of each automatic increase, or a lesser number of shares determined by the board of directors.

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

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.

On January 1, 2024, 3,304,820 shares of common stock were added to the shares authorized for issuance under the 2021 Plan, pursuant to the evergreen provision thereof, as determined by the Company’s board of directors.

The number of shares to be issued under the 2021 Plan did not increase pursuant to the evergreen provision thereof on January 1, 2023 nor January 1, 2025, 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 September 30, 2024 , there were an aggregate of 45,004,758 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which included 2,985,456 and 18,890,298 shares authorized to be issued upon the exercise of outstanding stock option grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 23,129,004 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively.

As of March 31, 2025 , there were an aggregate of 36,796,593 shares authorized to be issued under the 2020 Plan and the 2021 Plan, which included 1,036,823 and 23,677,879 shares authorized to be issued upon the exercise of outstanding stock option and restricted stock unit grants from the 2020 Plan and 2021 Plan, respectively, and 0 and 12,081,891 shares reserved for future issuance under the 2020 Plan and 2021 Plan, respectively.

Stock Option Valuation

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The risk-free interest rate is determined by reference to the U.S.

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.

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.

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,

Nine Months Ended

September 30,

Nine Months Ended

September 30,

Three Months Ended March 31,

Expected term (in years)

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Outstanding at December 31, 2024

Outstanding at September 30, 2024

Vested and expected to vest at September 30, 2024

Options exercisable at September 30, 2024

The weighted-average grant date fair value of stock options granted during the three and nine months ended September 30, 2024 was $ 0.74 and $ 2.06 , respectively, per share.

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 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 September 30, 2024 and 2023.

The total intrinsic value of stock options exercised was $ 0.1 million and $ 0.3 million for the three and nine months ended September 30, 2024 , respectively.

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.

Outstanding at March 31, 2025

Vested and expected to vest at March 31, 2025

Options exercisable at March 31, 2025

The weighted-average grant date fair value of stock options granted during the three months ended March 31, 2025 and 2024 was $ 0.93 and $ 2.53 , respectively, per share.

The total intrinsic value of stock options exercised was less than $ 0.1 million and $ 0 for the three months ended March 31, 2025 and 2024, respectively.

Restricted Stock Unit Activity

In February 2025, the Company’s board of directors approved restricted stock unit (“RSU” ) grants to the Company’s executive officers under the 2021 Plan.

An aggregate of 1,700,000 RSUs were issued at a grant date fair value of $ 1.61 per share.

The RSUs will vest over an eighteen-month period, with one-third of the RSUs vesting every six months following the grant date of February 15, 2025, subject to continuous service as of each vesting date.

The following table summarizes the Company’s RSU activity since December 31, 2024:

Weighted Average Grant Date Fair Value

Outstanding at December 31, 2024

Outstanding at March 31, 2025

Stock-Based Compensation Expense

The Company recorded stock-based compensation expense (service-based stock options and employee stock purchase plan) in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands):

Three Months Ended September 30,

Nine Months Ended

September 30,

Nine Months Ended

September 30,

The Company recorded stock-based compensation expense (service-based stock options, RSUs, and the Company ’s employee stock purchase plan) in the following expense categories of its condensed consolidated statements of operations and comprehensive loss (in thousands):

Three Months Ended March 31,

Research and development

Selling, general and administrative

As of September 30, 2024 , $ 0.9 million of share-based compensation expense was capitalized and recorded as Inventory in the accompanying condensed consolidated balance sheet.

In April 2024, David Hering ceased serving as the Company’s Chief Executive Officer and as a member of the Company’s board of directors.

Pursuant to his separation agreement, the Company recognized approximately $ 5.5 million of selling, general, and administrative related stock-based compensation expense associated with the accelerated vesting of a portion of his outstanding stock options, in accordance with the terms of his employment agreement.

As of September 30, 2024 , total unrecognized stock-based compensation expense related to unvested stock-based awards was $ 21.5 million, which is expected to be recognized over a weighted-average period of 2.3 years.

As of March 31, 2025, total unrecognized stock-based compensation expense related to unvested stock options was $ 19.0 million, which is expected to be recognized over a weighted-average period of 2.5 years.

As of March 31, 2025 , the total unrecognized stock-based compensation expense related to unvested RSUs was $ 2.5 million, which is expected to be recognized over a weighted-average period of 1.38 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 438,046 shares issued under the 2021 ESPP as of September 30, 2024 .

There were 587,291 shares issued under the 2021 ESPP as of March 31, 2025 .

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, pursuant to the evergreen provision thereof, 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, 2024 or January 1, 2023, pursuant to the evergreen provision thereof, as determined by the Company’s board of directors.

The number of shares to be issued under the 2021 ESPP did not increase pursuant to the evergreen provision thereof on January 1, 2023, January 1, 2024, nor January 1, 2025, as determined by the Company’s board of directors.

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

As of September 30, 2024 , 904,727 shares remained available for issuance under the 2021 ESPP.

During both the three and nine months ended September 30, 2024 , the Company recognized less than $ 0.1 million

in related stock-based compensation expense.

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

As of March 31, 2025 , 755,482 shares remained available for issuance under the 2021 ESPP.

During both the three months ended March 31, 2025 and 2024 , the Company recognized less than $ 0.1 million 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 nine months ended September 30, 2024 and 2023.

As of September 30, 2024 , there were 6,824,712 warrants outstanding and not yet vested at a weighted-average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 8.13 years.

For the three and nine months ended September 30, 2024 and 2023 , 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 months ended March 31, 2025 and 2024.

As of March 31, 2025 , there were 6,824,712 warrants outstanding and not yet vested at a weighted-average exercise price of $ 3.48 , with a weighted-average remaining contractual term of 7 .63 years.

For the three months ended March 31, 2025 and 2024 , 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.

3 unchanged sentences

Pursuant to the terms of the 401(k) Plan, the Company is required to make non-elective contributions of 3 % of eligible participants’ compensation.

For the three and nine months ended September 30, 2024 , the Company contributed $ 0.2 million and $ 0.5 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 both the three months ended March 31, 2025 and 2024, the Company contributed $ 0.2 million to the 401(k) Plan.

Net Loss per Share

Basic and diluted net loss per share attributable to common stockholders was calculated as follows (in thousands, except share and per share amounts):

Three Months Ended September 30,

Nine Months Ended September 30,

Three Months Ended March 31,

Net loss attributable to common stockholders

1 unchanged sentence

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

Shares of unvested restricted common stock are not considered outstanding for accounting purposes until vested and were excluded from the calculations of basic net loss per share attributable to common stockholders for the three and nine months ended September 30, 2023.

There were no shares of unvested restricted common stock for the three and nine months ended September 30, 2024.

There were no shares of unvested restricted common stock for the three months ended March 31, 2024.

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.

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 Three and Nine Months

Ended September 30,

For the Three and Nine Months

Ended September 30,

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 Three Months

Ended March 31,

For the Three Months

Ended March 31,

Stock options to purchase common stock

Unvested restricted common stock

Restricted stock units

Warrants to purchase common stock

Related-Party Transactions

As of September 30, 2024 and December 31, 2023 , an aggregate of $ 1.3 million and $ 0.7 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 and was included in accrued expenses.

As of September 30, 2024 and December 31, 2023 , 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 March 31, 2025 and December 31, 2024 , an aggregate of $ 0.5 million and $ 1.3 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 and was included in accrued expenses.

As of March 31, 2025 and December 31, 2024 , 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 both the three and nine months ended September 30, 2024, 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 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 both the three and nine months ended September 30, 2024, the Company expensed $ 0.5 million of royalties as costs of product revenue and reserves all rights under the Adimab Assignment Agreement and the applicable law.

During both the three and nine months ended September 30, 2023 , the Company did no t recognize any costs of product revenue with respect to royalties under the Adimab Assignment Agreement.

During both the three months ended March 31, 2025 and 2024, the Company did no t recognize any IPR&D expense with respect to contingent consideration payable under the Adimab Assignment Agreement.

During both the three months ended March 31, 2025 and 2024 , 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 months ended March 31, 2025, the Company expensed $ 0.5 million of royalties as costs of product revenue, while reserving all rights under the Adimab Assignment Agreement and the applicable law.

During the three months ended March 31, 2024 , the Company did no t recognize any costs of product revenue with respect to royalties 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 the three and nine months ended September 30, 2024 , the Company recognized $ 0.6 million and $ 1.8 million, respectively, of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.

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 under the Adimab Collaboration Agreement.

During both the three and nine months ended September 30, 2024 , 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 Collaboration Agreement.

During both the three and nine months ended September 30, 2024 , the Company did no t recognize any IPR&D expense related to an option fee.

During both the three and nine months ended September 30, 2023 , 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, 2024 , the Company did no t recognize any IPR&D expense related to a drug delivery fee or optimization 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 and $0.2 million of IPR&D expense related to an optimization completion fee.

During both the three months ended March 31, 2025 and 2024 , the Company recognized $ 0.6 million of research and development expense related to the quarterly fee under the Adimab Collaboration Agreement.

During both the three months ended March 31, 2025 and 2024 , 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 Collaboration Agreement.

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), including an annual fee of single digit millions on each of the first four anniversaries of the Adimab Platform Transfer Agreement Effective Date.

During both the three and nine months ended September 30, 2024 and 2023, the Company recognized a portion of the annual fee as research and development expense under the Adimab Platform Transfer Agreement.

During both the three months ended March 31, 2025 and 2024 , the Company recognized $ 0.5 million of research and development expense related to the annual fee under the Adimab Platform Transfer Agreement.

Adimab DNA Sequencing Services Agreement

In May 2023, as amended in January 2024, the Company entered into a Services Agreement with Adimab for Adimab to perform DNA sequencing on yeast samples provided by the Company, and the delivery of the resulting data and information to the Company (the “Adimab DNA Sequencing Services Agreement”).

In May 2023, as amended in January 2024 and January 2025, the Company entered into a Services Agreement with Adimab for Adimab to perform DNA sequencing on yeast samples provided by the Company, and the delivery of the resulting data and information to the Company (the “Adimab DNA Sequencing Services Agreement”).

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 both the three and nine months ended September 30, 2024 , 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 both 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

Population Health Partners, L.P.

Under the PHP MSA and PHP Work Order, the Company was obligated to pay cash compensation for services and deliverables (see Note 8).

Tamsin Berry, a member of the Company’s board of directors, is a Limited Partner of PHP.

During the three and nine months ended September 30, 2024 , the Company did no t recognize any 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 services performed by PHP in connection with the PHP Work Order, which terminated in accordance with its terms in May 2023.

As of September 30, 2024 , no amounts were due to PHP by the Company, and no amounts were due from PHP to the Company.

During both the three months ended March 31, 2025 and 2024, 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.

Segment Reporting

The Company operates as a single reportable and operating segment dedicated to the research and development, commercialization, and sale of mAbs in the U.S to deliver protection from serious viral infectious diseases.

The determination of a single reportable segment is consistent with the consolidated financial information regularly reviewed by the Chief Operating Decision Maker (the “CODM”) in assessing performance and deciding how to allocate resources on a consolidated basis.

The CODM assesses performance and allocates resources based on the Company’s net loss reported on the consolidated statements of operations and comprehensive loss.

The CODM’s area of focus is period over period fluxes and budget-to-actual variances when assessing performance and deciding how to allocate resources.

The following table presents information about reported segment revenues, and significant segment expenses as provided to the CODM.

Three Months Ended March 31,

Product revenue, net

Total revenue

Operating costs and expenses:

Cost of product revenue

Direct, external research and development expenses by program:

Total direct, external research and development expenses by program

Unallocated research and development expenses (1)

Other segment items (2)

Stock-based compensation

Total operating costs and expenses

Loss from operations

Other income:

Other income, net (3)

Total other income, net

(1) Includes personnel related expenses (excluding research and development stock-based compensation) and external discovery-related and other costs.

(2) Includes commercial, general and administrative personnel related costs (excluding stock-based compensation), professional and consulting fees and other costs.

(3) Includes interest income of $ 628 and $ 2,599 for the three months ended March 31, 2025 and 2024 , respectively.

Subsequent Events

On April 18, 2025, the Company entered into a Loan and Security Agreement (the “Loan Agreement”) with Silicon Valley Bank, a division of First Citizens Bank & Trust Company, as lender (the “Lender” ).

The Loan Agreement provides for a senior secured term loan facility in an aggregate principal amount of up to $ 30 million (the “Term Facility”) consisting of (a) Term A Loans in an aggregate principal amount of up to $ 10 million, which shall be available to be drawn from and after August 15, 2025 through December 31, 2026 upon compliance with certain financial covenants and conditions, (b) Term B Loans in an aggregate principal amount of up to $ 10 million, which shall be available to be drawn during the period commencing on the date of the achievement of certain net product revenue milestones and ending on June 30, 2027 , and (c) Term C Loans in an aggregate principal amount of up to $ 10 million, which shall be available to be drawn during the period commencing on the date of the achievement of certain net product revenue milestones and ending on June 30, 2027 .

The proceeds of the Term Facility may be used for working capital and general business purposes.

The loans under the Term Facility are due and payable on March 1, 2029 and bear interest that is payable monthly, commencing with the month in which any loans are funded under the Term Facility, in arrears at a per annum rate, subject to increase during an Event of Default (as defined in the Loan Agreement), equal to the greater of (x) the Wall Street Journal prime rate minus 0.25%, subject to a 9.00% cap, and (y) 6.00%.

Commencing on April 1, 2027 , which date may be extended to April 1, 2028 upon the achievement of certain net product revenue milestones (the “Interest-Only Period Extension”), the Company is required to repay the principal of the Term Facility in 24 consecutive equal monthly installments or, in the case of the Interest-Only Period Extension, 12 consecutive equal monthly installments.

At maturity, or if earlier prepaid, the Company will also be required to pay a final payment fee equal to 4.50 % of the aggregate principal amount of the loans advanced under the Term Facility.

The Loan Agreement provides for an unused term loan commitment fee equal to 1.00 % of the Term Facility upon the earliest to occur of (a) July 1, 2027, (b) the occurrence of an Event of Default under the Loan Agreement and (c) the termination of the Loan Agreement;

provided, that such fee will be waived by the Lender in the event that the Company has requested and the Lender has funded any loans under the Term Facility prior to such date.

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