What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-05-15 · 129 added, 57 removed, 289 unchanged (39% of the section changed)

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• our expectations related to VYD2311, our next generation monoclonal antibody (“mAb”) candidate for COVID-19, and the potential of VYD2311 to offer the ability to deliver clinically meaningful titer levels through more system- and patient-friendly means;

• our expectations regarding availability of a rapid pathway to potential Biologics License Application ("BLA") approval for VYD2311 for the prevention of COVID-19 and the compact pivotal clinical trial that could substantiate it;

• the anticipated timing, design, progress and results of preclinical studies and clinical trials of our product candidates, including statements regarding initiation or completion of studies or trials and related preparatory work, the period during which results of any studies or trials will become available, and potential regulatory submissions;

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• our goal of establishing streamlined development pathways to efficiently introduce new mAb candidates targeting SARS-CoV-2;

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

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

• our plans regarding SARS-CoV-2 variant monitoring of antiviral activity as part of our ongoing industrial virology effort;

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• our ability to identify and develop future product candidates;

• our expectations regarding the SPEAR Study Group, including its anticipated focus, goals and plans;

• our estimates of our expenses, ongoing losses, future potential revenue, capital requirements and our need for or ability to obtain additional funding;

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

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, we announced completion of recruitment in our Phase 1 clinical trial of VYD2311, as well as positive clinical data for both safety and pharmacokinetics.

We expect additional data readouts from the Phase 1 clinical trial and VYD2311 program throughout 2025.

The Phase 1/2 randomized, blinded, placebo-controlled clinical trial evaluated escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants.

The Phase 1/2 clinical trial was conducted in Australia and evaluated 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 June 2025, we announced positive full Phase 1/2 clinical data for VYD2311 for both safety and pharmacokinetics.

In August 2025, we announced alignment with advice from the FDA on a compact and, therefore, rapid pathway to potential BLA approval for VYD2311 for the prevention of COVID-19.

As part of a recent Type C meeting, the FDA advised that a single, Phase 2/3 randomized, double-blind, placebo-controlled trial evaluating mAb efficacy from a relatively modest number of RT-PCR-confirmed symptomatic COVID-19 disease events could support a BLA submission for VYD2311 for the prevention of COVID-19 in a broad population of Americans (12 years of age and older, weighing at least 40kg), including immunocompromised people, subject to agreement on safety database size and pending full protocol review.

Like pemivibart, VYD2311 was engineered from adintrevimab, our investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19.

In July 2025, we announced that we had formed the SPEAR (Spike Protein Elimination and Recovery) Study Group with leading investigators to structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing

anti-SARS-CoV-2 spike protein mAb therapy in people suffering from Long COVID or Post-Vaccination Syndrome (PVS).

The SPEAR Study Group intends to launch multi-center translational clinical research on Long COVID and PVS using next-generation antibodies like our investigational mAb candidate VYD2311.

Globally, COVID-19 has caused millions of deaths and lasting health problems in many survivors and remains a significant global health concern, particularly for immunocompromised individuals.

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COVID-19 persists and continues to impact patients, notably those who are immunocompromised, and combating this disease will require a variety of effective and safe prevention and treatment options for years to come.

By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and nearly five years in the COVID-19 space, we aim to develop mAbs that could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications.

By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and over five years in the COVID-19 space, we aim to develop mAbs that could be used in prevention or treatment of serious viral diseases, starting with COVID-19 and potentially expanding into other high-need indications.

PEMGARDA 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).

The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying

the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.

The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C.

§ 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

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

Since our inception, we have incurred significant losses, including a net loss of $16.3 million for the three months ended March 31, 2025.

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

Since our inception, we have incurred significant losses, including a net loss of $30.9 million for the six months ended June 30, 2025.

As of June 30, 2025, we had an accumulated deficit of $932.9 million.

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

In addition, our losses from operations may fluctuate significantly from period to period depending on the timing of our clinical trials and our expenditures on other research and development activities, manufacturing activities, and commercialization efforts.

manufacturing activities, and commercialization efforts.

Our expenses could increase substantially in connection with our ongoing activities, as we:

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Product revenue, net consists of product revenue earned on the sales of PEMGARDA in the U.S.

Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances, trade discounts and distributor fees, government chargebacks, product returns and other incentives such as co-pay assistance programs.

Cost of Product Revenue

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

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

Our research and development costs consist primarily of external costs, such as fees paid to a CDMO, CROs and consultants in connection with our nonclinical studies, preclinical studies, clinical trials and product manufacturing.

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Selling, general and administrative expenses consist primarily of salaries, bonuses, benefits, third-party fees and other compensation-related costs, including stock-based compensation, for our personnel and external contractors involved in our executive, finance, legal, business development and other administrative functions, as well as our commercial function.

Selling, general and administrative expenses also include costs incurred for outside services associated with such functions, including legal fees relating to patent and corporate matters;

Selling, general and administrative expenses also include costs incurred for outside services associated with such functions, including

legal fees relating to patent and corporate matters;

professional fees for accounting, auditing, tax and administrative consulting services;

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We also expect to incur additional intellectual property-related expenses as we file additional patent applications to protect innovations arising from our research and development activities.

Through March 31, 2025, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.

Through June 30, 2025, we have operated as a hybrid company.

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

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We continue to monitor the manner in which countries will enact legislation to implement the Pillar Two framework proposed by the Organisation for Economic Co-operation and Development, which proposes a 15% global corporate minimum tax.

As of March 31, 2025, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.

As of June 30, 2025, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.

While we do not expect these rules to have a material impact on our effective tax rate, we continue to monitor these initiatives on a global basis.

Results of Operations

Comparison of the three months ended March 31, 2025 and 2024

The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024:

Three Months Ended March 31,

Comparison of the three months ended June 30, 2025 and 2024

The following table summarizes our results of operations for the three months ended June 30, 2025 and 2024:

Three Months Ended June 30,

(in thousands)

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Product Revenue, Net

Product revenue, net was $11.3 million for the three months ended March 31, 2025.

There was no product revenue, net for the three months ended March 31, 2024.

The $11.3 million increase is the result of product sales following the launch of PEMGARDA in April 2024.

Product revenue, net was $11.8 million and $2.3 million for the three months ended June 30, 2025 and 2024, respectively.

The $9.5 million increase is the result of increased product sales following the launch of PEMGARDA in April 2024.

Cost of Product Revenue

Cost of product revenue was $0.8 million for the three months ended March 31, 2025.

There was no cost of product revenue for the three months ended March 31, 2024.

The $0.8 million increase is the result of PEMGARDA product sales following launch and certain period costs.

Cost of product revenue was $0.7 million and $0.1 million for the three months ended June 30, 2025 and 2024, respectively.

The $0.6 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.

We began capitalizing our inventory costs in March 2024, in connection with EUA from the FDA and based upon our expectation that these costs would be recoverable through commercialization of PEMGARDA.

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Research and Development Expenses

Three Months Ended March 31,

Three Months Ended June 30,

(in thousands)

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(2) In March 2024, we announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.

Research and development expenses were $10.6 million for the three months ended March 31, 2025, compared to $31.2 million for the three months ended March 31, 2024.

Research and development expenses were $9.6 million for the three months ended June 30, 2025, compared to $30.3 million for the three months ended June 30, 2024.

The $20.8 million decrease in research and development expenses was primarily due to the following:

• Decrease in direct costs related to our pemivibart program resulted from decrease of $11.9 million in contract costs for commercial manufacturing, $4.8 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.4 million in nonclinical expenses, and $0.2 million in other external expenses;

• Decrease in direct costs related to our VYD2311 program resulted from decrease of $0.4 million in contract costs for clinical manufacturing and $0.2 million in nonclinical expense, partially offset by increase of $0.2 million in contract research costs for our Phase 1 clinical trial;

• Decrease in direct costs related to our pemivibart program resulted from decrease of $3.9 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.2 million in nonclinical expenses, and $0.2 million in other external costs, partially offset by increase of $0.6 million in contract development and manufacturing primarily related to increased storage costs;

• Decrease in direct costs related to our VYD2311 program resulted from decrease of $15.4 million in contract costs for clinical and commercial manufacturing and $1.0 million in nonclinical expense, partially offset by increase of $0.2 million in contract research costs for our Phase 1/2 clinical trial;

• The direct costs related to our adintrevimab program remained relatively consistent between periods;

• Decrease in personnel related costs resulted from decrease of $0.3 million in headcount-related costs;

• Decrease in external discovery-related and other costs resulted from decrease of $0.5 million in contract development and manufacturing costs related to our pipeline candidates.

Selling, General and Administrative Expenses

Three Months Ended March 31,

Three Months Ended June 30,

(in thousands)

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Total selling, general and administrative expenses

Selling, general and administrative expenses were $16.8 million for the three months ended March 31, 2025, compared to $14.9 million for the three months ended March 31, 2024.

The $1.8 million increase in selling, general and administrative expenses was primarily due to the following:

• Increase in professional and consultant fees resulted from increase of $0.7 million in sales and marketing costs and $0.2 million in professional service fees;

Selling, general and administrative expenses were $16.6 million for the three months ended June 30, 2025, compared to $21.1 million for the three months ended June 30, 2024.

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

• Decrease in personnel related costs primarily related to decrease of $5.2 million in stock-based compensation expense, partially offset by $0.4 million increase in headcount-related costs.

The decrease in stock-based compensation expense was primarily due to stock-based compensation expense recognized in 2024 associated with

the accelerated vesting of a portion of the outstanding stock options granted to our former Chief Executive Officer, in accordance with the terms of his employment agreement;

• Decrease in professional and consultant fees resulted from decrease of $0.5 million related to sales and marketing costs and $0.1 million in insurance cost, partially offset by increase of $0.4 million in professional service fees;

• Increase in other costs primarily resulted from an increase of travel costs.

Other income was $0.4 million and $2.0 million for the three months ended June 30, 2025 and 2024, respectively, in each case consisting primarily of interest earned on our invested cash balances.

Comparison of the six months ended June 30, 2025 and 2024

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:

Six Months Ended June 30,

(in thousands)

Product revenue, net

Total revenue

Operating costs and expenses:

Cost of product revenue

Research and development

Selling, general and administrative

Total operating costs and expenses

Loss from operations

Other income:

Other income, net

Total other income, net

The following discussion presents the components of our expenses for the periods presented:

Product Revenue, Net

Product revenue, net was $23.1 million and $2.3 million for the six months ended June 30, 2025 and 2024, respectively.

The $20.8 million increase is the result of increased product sales following the launch of PEMGARDA in April 2024.

Cost of Product Revenue

Cost of product revenue was $1.5 million and $0.1 million for the six months ended June 30, 2025 and 2024, respectively.

The $1.4 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.

Prior to the capitalization of our inventory costs, such costs were recorded as research and development expenses in the period incurred.

Had our pre-EUA manufacturing costs been capitalized, our reported margins would approach 80%.

Research and Development Expenses

Six Months Ended June 30,

(in thousands)

Direct, external research and development expenses by program:

Pemivibart (1)

Unallocated research and development expenses:

Personnel related (including stock-based compensation)

External discovery-related and other costs

Total research and development expenses

(1) In March 2023, we announced the nomination of VYD222 (pemivibart) as a novel mAb therapeutic option for COVID-19.

(2) In March 2024, we announced the nomination of VYD2311 as a novel mAb therapeutic option for COVID-19.

Research and development expenses were $20.2 million for the six months ended June 30, 2025, compared to $61.5 million for the six months ended June 30, 2024.

The $41.3 million decrease in research and development expenses was primarily due to the following:

• Decrease in direct costs related to our pemivibart program resulted from decrease of $11.3 million in contract costs for commercial manufacturing, $8.6 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.7 million in nonclinical costs, and $0.4 million in other external costs;

• Decrease in direct costs related to our VYD2311 program resulted from decrease of $15.9 million in contract costs for clinical and commercial manufacturing and $1.2 million in nonclinical expense, partially offset by increase of $0.5 million in contract research costs for our Phase 1/2 clinical trial;

• The direct costs related to our adintrevimab program remained relatively consistent between periods;

• Decrease in personnel related costs resulted from decrease of $3.0 million in headcount-related costs;

• Decrease in external discovery-related and other costs resulted from $0.6 million in contract development and manufacturing expense related to our pipeline candidates.

Selling, General and Administrative Expenses

Six Months Ended June 30,

(in thousands)

Personnel-related costs

Professional and consultant fees

Total selling, general and administrative expenses

Selling, general and administrative expenses were $33.3 million for the six months ended June 30, 2025, compared to $36.0 million for the six months ended June 30, 2024.

The $2.7 million decrease in selling, general and administrative expenses was primarily due to the following:

• Decrease in personnel related costs resulted from decrease of $6.9 million in stock-based compensation expense, partially offset by increase of $2.2 million in headcount-related costs.

The decrease in stock-based compensation expense was primarily due to stock-based compensation expense recognized in 2024 associated with the accelerated vesting of a portion of the outstanding stock options granted to our former Chief Executive Officer, in accordance with the terms of his employment agreement;

• Increase in professional and consultant fees resulted from increase of $0.6 million in professional service fees and $0.2 million in sales and marketing costs, partially offset by decrease of $0.2 million in insurance costs;

• Increase in other costs primarily resulted from increase of $1.0 million in travel costs and $0.3 million in software licensing costs.

Other income was $0.6 million and $2.6 million for the three months ended March 31, 2025 and 2024, respectively, in each case consisting primarily of interest earned on our invested cash balances.

Other income was $1.0 million and $4.6 million for the six months ended June 30, 2025 and 2024, respectively, in each case consisting primarily of interest earned on our invested cash balances.

Liquidity and Capital Resources

Sources of Liquidity

Through March 31, 2025, we have incurred significant operating losses and negative cash flows from operations.

Through June 30, 2025, we have incurred significant operating losses and negative cash flows from operations.

Although we received an EUA from the FDA for PEMGARDA in March 2024, we may continue to incur significant expenses and potential operating losses for the foreseeable future as we continue to commercialize PEMGARDA and advance the development of our other product candidates.

To date, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, with aggregate net proceeds from our IPO in August 2021 of $327.5 million, and with net proceeds of $39.3

million from sales of our common stock under the Sales Agreement (as defined below).

After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA.

As of March 31, 2025, we had cash and cash equivalents of $48.1 million.

As of June 30, 2025, we had cash and cash equivalents of $34.9 million.

Sales Agreement

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

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

As of June 30, 2025, $34.5 million remained available for sale under the Sales Agreement.

Loan Agreement

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

As of June 30, 2025, we had not satisfied the net product revenue milestone required to be eligible to access proceeds from the Term Facility as of the earliest draw down date, August 15, 2025.

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%.

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

Three Months Ended March 31,

Six Months Ended June 30,

(in thousands)

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Net cash provided by financing activities

Effect of exchange rate changes on cash and cash equivalents

Net decrease in cash and cash equivalents

Operating Activities

During the three months ended March 31, 2025, operating activities used $21.1 million of cash, primarily due to our net loss of $16.3 million and changes in our operating assets and liabilities of $8.4 million, partially offset by non-cash charges of $3.6 million.

The changes in our operating assets and liabilities primarily consisted of a $10.0 million decrease in accrued expenses, a $1.6 million decrease in accounts payable, and a $0.4 million decrease in operating lease liabilities, partially offset by a $2.3 million decrease in accounts receivable, and a $1.3 million decrease in prepaid expenses and other current assets.

During the six months ended June 30, 2025, operating activities used $34.4 million of cash, primarily due to our net loss of $30.9 million and changes in our operating assets and liabilities of $10.8 million, partially offset by non-cash charges of $7.3 million.

The changes in our operating assets and liabilities primarily consisted of a $24.6 million decrease in accrued expenses, a $0.7 million decrease in operating lease liabilities, and a $0.1 million increase in inventory, partially offset by a $7.7 million increase in accounts payable, $4.8 million decrease in prepaid expenses and other current assets, and $2.1 million decrease in accounts receivables.

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

During the six months ended June 30, 2024, operating activities used $91.8 million of cash, primarily due to our net loss of $90.7 million and changes in our operating assets and liabilities of $16.0 million, partially offset by non-cash charges of $14.9 million.

The changes in our operating assets and liabilities primarily consisted of a $15.8 million decrease in accrued expenses, a $2.9 million increase in accounts receivables, a $2.6 million increase in inventory, a $1.6 million increase in other non-current assets, a $0.8 million decrease in operating lease liabilities, a $0.8 million decrease in other non-current liabilities and a $0.6 million decrease in accounts payable, partially offset by a $7.4 million decrease in prepaid expenses and other current assets and a $1.7 million increase in deferred revenue.

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

During the three months ended March 31, 2024, operating activities used $50.2 million of cash, primarily due to our net loss of $43.5 million and changes in our operating assets and liabilities of $12.6 million, partially offset by non-cash charges of $5.9 million.

The changes in our operating assets and liabilities primarily consisted of a $7.0 million decrease in accrued expenses, a $6.8 million decrease in accounts payable, a $1.7 million increase in other non-current assets, a $0.7 million decrease in other non-current liabilities, a $0.4 million decrease in operating lease liabilities, and a $0.1 million increase in inventory, partially offset by a $4.0 million decrease in prepaid expenses and other current assets.

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

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

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

Investing Activities

Net cash used in investing activities during both the three months ended March 31, 2025 and 2024, consisted of $0.1 million in purchases of property and equipment.

Net cash used in investing activities during the six months ended June 30, 2025 consisted of $0.2 million in purchases of property and equipment.

Net cash used in investing activities during the six months ended June 30, 2024 consisted of $0.1 million in purchases of property and equipment.

Financing Activities

Net cash provided by financing activities during the three months ended March 31, 2025 consisted of $0.1 million from the exercises of stock options and the issuance of common stock under the employee stock purchase plan, offset by $0.1 million in payments for offering costs related to the Sales Agreement.

Net cash provided by financing activities during the three months ended March 31, 2024 consisted of $39.3 million from the issuance of common stock under the Sales Agreement and $0.1 million from the issuance of common stock under the employee stock purchase plan, partially offset by $0.3 million in payments for offering costs related to the Sales Agreement.

Net cash provided by financing activities during the six months ended June 30, 2025 consisted of $0.2 million from the exercises of stock options and the issuance of common stock under the employee stock purchase plan, partially offset by $0.1 million in payments for offering costs related to the Sales Agreement.

Net cash provided by financing activities during the six months ended June 30, 2024 consisted of $39.3 million from the issuance of common stock under the Sales Agreement, $0.2 million from exercises of stock options and $0.2 million from the issuance of common stock under the employee stock purchase plan, partially offset by $0.4 million in payments for offering costs related to the Sales Agreement.

Funding Requirements

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Contractual Obligations and Commitments

Through March 31, 2025, we committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Services Agreement with WuXi Biologics, which was entered into in December 2020, amended and restated in August 2021 and further amended and restated in September 2023 (as amended and restated, the “Commercial Manufacturing Agreement”).

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, we 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 was included in accounts payable and accrued expenses and is expected to be paid in 2025.

Through June 30, 2025, we committed to noncancelable purchase obligations related to commercial drug substance and drug product manufacturing under the Commercial Manufacturing Services Agreement with WuXi Biologics, which was entered into in December 2020, amended and restated in August 2021 and further amended and restated in September 2023 (as amended and restated, the “Commercial Manufacturing Agreement”).

As of June 30, 2025, the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $25.9 million, which was included in accounts payable and accrued expenses.

The remaining balance is expected to be paid in 2025.

Through June 30, 2025, we 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 June 30, 2025, the total remaining contractually binding purchase obligations due to WuXi Biologics was $3.5 million, which was included in accounts payable and accrued expenses.

The remaining balance is expected to be paid in 2025.

Critical Accounting Policies and Significant Judgments and Estimates

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis