What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-13 compared with 2026-05-14 · 164 added, 87 removed, 318 unchanged (44% of the section changed)

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Food and Drug Administration (“FDA”) in March 2024, including our expectations about the potential market opportunity;

• our expectations related to the future termination of the PEMGARDA EUA, to be effective on June 29, 2027, following the U.S.

Department of Health and Human Services (“HHS”) announcement on June 30, 2026, providing advance notice of termination of the COVID-19 emergency use declaration for drugs and biological products, and our dialogue with the FDA about appropriate next steps for PEMGARDA;

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

• 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;

• our devotion to delivering protection from serious viral infectious diseases, and our commitment to developing a robust pipeline of product candidates that could be used in prevention or treatment of serious viral infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles;

• our devotion to delivering protection from serious viral infectious diseases, including our intent to pursue permanent, high quality medical protection from COVID-19 infection for immune-compromised and other vulnerable Americans, and our commitment to developing a robust pipeline of product candidates that could be used in prevention or treatment of serious viral infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as measles and respiratory syncytial virus (“RSV”);

• 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;

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

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 infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as respiratory syncytial virus (“RSV”) and measles.

By leveraging our capabilities, which we have developed through our experience with adintrevimab and pemivibart and over six years in the COVID-19 space, we aim to develop mAbs that could be used in prevention or treatment of serious viral infectious diseases, starting with COVID-19 and expanding into other high-need indications, such as measles and respiratory syncytial virus (“RSV”).

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

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

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.

PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies.

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

On June 30, 2026, HHS provided advance notice of the termination of the declaration, which will take effect after a twelve-month transition period ending on June 29, 2027.

Consequently, the EUA for PEMGARDA is set to terminate on June 29, 2027.

Consistent with EUA transition processes, we are in dialogue with the FDA about appropriate next steps for PEMGARDA.

We intend to pursue permanent, high quality medical protection from COVID-19 infection for immune-compromised and other vulnerable Americans.

In January 2024, we nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate.

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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 (“IM”) administration and subcutaneous administration, which are designed to be more healthcare system- and patient-friendly than IV administration.

In June 2025, we announced positive full Phase 1/2 clinical data for VYD2311 for both safety and

pharmacokinetics.

In June 2025, we announced positive full Phase 1/2 clinical data for VYD2311 for both safety and pharmacokinetics.

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.

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In April 2026, we announced that we conducted a prospectively designed, conservative, algorithmic sample size re-estimation pooled, blinded analysis for the DECLARATION clinical trial aimed at ensuring adequate COVID-19 clinical events and associated statistical power given the variability of COVID-19 attack rates.

As of the sample-size re-estimation analysis, conducted when the first 1,500 (of 1,818 total) subjects reached Day 45, clinical events accrued to date could support statistical powering for the high end of anticipated VYD2311 efficacy levels with approximately half of the base DECLARATION clinical trial still to go.

The sample size re-estimation was designed conservatively with the aim of accomplishing strong statistical power to accommodate a range of potential VYD2311 efficacy results and COVID events in the trial, and upsizing was triggered.

The DECLARATION upsizing includes approximately 500 additional subjects, in addition to 1,818 total randomized subjects in the initial trial population.

The DECLARATION upsizing included approximately 500 additional subjects, in addition to 1,818 total randomized subjects in the initial trial population.

In June 2026, we announced completion of enrollment in the upsized DECLARATION clinical trial.

Total enrollment of the trial is approximately 2,400 participants.

DECLARATION is designed to support potential BLA submission.

Depending on recruitment rates following the trial upsizing, top-line data from DECLARATION are expected in the third quarter of 2026.

Top-line data from DECLARATION are planned later in the third quarter of 2026.

In February 2026, we announced alignment with the FDA on LIBERTY, which is designed as a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of (1) VYD2311, (2) an mRNA COVID vaccine, and (3) co-administered VYD2311 with an mRNA COVID vaccine.

Additionally, we have agreed with the FDA on an initial Pediatric Study Plan for an efficient safety and immunobridging clinical trial to support potential BLA for VYD2311 in children aged 0-11 years.

In June 2026, we announced initiation and completion of enrollment in LIBERTY.

Total enrollment of the trial is approximately 210 participants.

The LIBERTY clinical trial is fully dosed, with top-line data anticipated later in the third quarter of 2026.

Additionally, we have agreed with the FDA on an initial Pediatric Study Plan for an efficient safety and immunobridging clinical trial to support potential BLA submission for VYD2311 in children aged 0-11 years.

This DRUMMER pediatric clinical trial will be actioned only if the pivotal DECLARATION clinical trial is successful.

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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.

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.

In January 2026, we and the SPEAR Study Group announced plans to initiate a Phase 2 clinical trial evaluating VYD2311 in individuals with Long COVID or COVID vaccine injury.

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We expect to advance VBY329 toward IND readiness in the second half of 2026.

Also, in April 2026, we announced the discovery and

advancement of VMS063, a novel, highly potent, half-life-extended, high resistance barrier measles mAb candidate.

We have begun IND-enablement and regulatory outreach to support rapid VMS063 development, with the goal of expedited development with target IND readiness in late 2026.

Also, in April 2026, we announced the discovery and advancement of VMS063, a novel, highly potent, half-life-extended, high resistance barrier measles mAb candidate.

We have begun IND-enablement and regulatory outreach to support rapid VMS063 development, and expect to advance VMS063 toward IND readiness in the second half of 2026.

Through our proprietary technology platform, we continue to investigate additional mAbs for protection and treatment of other important infectious diseases.

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In addition, we expect to continue to rely on third parties for clinical trials and the manufacture and testing of our product candidates, as well as to perform ongoing research and development and other services on our behalf.

Since our inception and through March 31, 2026, we have financed our operations primarily through the sale and issuance of preferred and common stock, including net proceeds of $464.7 million from sales of our preferred stock, net proceeds of $327.5 million from sales of our common stock from our initial public offering (“IPO”), net proceeds of $72.7 million from sales of our common stock under the Sales Agreement (as defined below) and net proceeds of $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below).

Since our inception and through June 30, 2026, we have financed our operations primarily through the sale and issuance of preferred and common stock, including net proceeds of $464.7 million from sales of our preferred stock, net proceeds of $327.5 million from sales of our common stock from our initial public offering (“IPO”), net proceeds of $92.1 million from sales of our common stock under the Sales Agreement (as defined below) and net proceeds of $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below).

We have also funded our operations from sales of PEMGARDA.

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 $41.4 million for the three months ended March 31, 2026.

As of March 31, 2026, we had an accumulated deficit of $995.9 million.

Since our inception, we have incurred significant losses, including a net loss of $85.8 million for the six months ended June 30, 2026.

As of June 30, 2026, we had an accumulated deficit of $1,040.3 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.

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

• continue to commercialize PEMGARDA;

• continue to commercialize PEMGARDA while it remains authorized, and continue our discussions with the FDA about appropriate next steps for PEMGARDA in advance of the PEMGARDA EUA termination effective date of June 29, 2027;

• advance the development of VYD2311 and prepare for its potential commercial launch, if approved, as well as advance development of our other product candidates, such as VBY329 and VMS063;

• initiate and conduct clinical trials of our product candidates, including advancement of our REVOLUTION clinical program;

• initiate and conduct clinical trials of our product candidates, including continued advancement of our REVOLUTION clinical program;

• develop product candidates in any new indications or patient populations;

• advance our preclinical and discovery programs, such as RSV and measles, including development and screening of additional antibodies, as well as engage in ongoing SARS-CoV-2 variant monitoring and testing;

• advance our preclinical and discovery programs, such as measles and RSV, including development and screening of additional antibodies, as well as engage in ongoing SARS-CoV-2 variant monitoring and testing;

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

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

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

We may never obtain regulatory authorization or approval for any of our product candidates other than the EUA for PEMGARDA, which is set to terminate on June 29, 2027.

Even with product sales, we may not become profitable.

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

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

On June 30, 2026, HHS provided advance notice of the termination of the declaration, which will take effect after a twelve-month transition period ending on June 29, 2027.

Consequently, the EUA for PEMGARDA is set to terminate on June 29, 2027.

When the EUA for PEMGARDA is terminated, we will be unable to sell PEMGARDA unless we are successful in obtaining regulatory approval, the process for which may be lengthy, time consuming and inherently unpredictable.

We have not obtained regulatory authorization or approval

for any other product candidates, and we do not expect to generate any significant revenue from the sale of other product candidates until we complete clinical development, submit regulatory filings and receive regulatory approval for such product candidates, if ever.

Cost of Product Revenue

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

Our research and development expenses will increase as we continue advancing VYD2311 through clinical development, particularly as we advance the REVOLUTION clinical program, pursue EUA or regulatory approval of our product candidates, and continue to discover and develop additional product candidates.

Our research and development expenses will increase as we continue advancing VYD2311 through clinical development, particularly as we advance the REVOLUTION clinical program, pursue regulatory approval of our product candidates, and continue to discover and develop additional product candidates.

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

We are also unable to predict when, if ever, material net cash inflows will commence from sales or licensing of our product candidates.

We are also unable to predict when, if ever, material

net cash inflows will commence from sales or licensing of our product candidates.

This is due to the numerous risks and uncertainties associated with drug development, including the uncertainty of:

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• the terms and timing of any collaboration, license or other arrangement, including the terms and timing of any milestone payments thereunder;

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

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

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

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

• timely receipt of regulatory authorizations or approvals from applicable regulatory authorities, including our eligibility for any expedited regulatory review and approval approaches that we may pursue for our product candidates;

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

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We may elect to discontinue, delay or modify clinical trials of some product candidates or focus on others.

In emergency situations, such as a pandemic, and with a declaration of a public health emergency by the U.S.

Secretary of the Department of Health and Human Services (“HHS”), the FDA has the authority to issue an EUA.

While the COVID-19 public health emergency declared by HHS under the Public Health Service Act expired on May 11, 2023, this does not impact the FDA’s ability to authorize COVID-19 drugs and biological products for emergency use pursuant to the relevant declaration under Section 564 of the FDCA.

On March 22, 2024, we received EUA from the FDA for PEMGARDA.

There can be no assurance that the public health emergency in the U.S.

declared under the FDCA will continue to be in place for an extended period of time, that any of our other product candidates will be granted an EUA by the FDA, if we apply for such an authorization, or that we would be able to maintain an EUA, such as the EUA received for PEMGARDA, for an extended period of time.

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 of the FDCA, unless the declaration is terminated or authorization revoked sooner.

Acquired In-Process Research and Development Expenses

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These costs relate to the operation of the business, unrelated to the research and development function, or any individual program.

Our selling, general and administrative expenses will increase in the future as our business expands and we increase our headcount to support the expected growth in our research and development activities and the commercialization of any authorized or approved product candidates, such as PEMGARDA.

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

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, 2026, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.

Through June 30, 2026, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.

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

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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, 2026, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.

As of June 30, 2026, 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, 2026 and 2025

The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Three Months Ended March 31,

Comparison of the three months ended June 30, 2026 and 2025

The following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:

Three Months Ended June 30,

(in thousands)

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Product Revenue, Net

Product revenue, net was $13.7 million and $11.3 million for the three months ended March 31, 2026 and 2025, respectively.

Product revenue, net was $14.3 million and $11.8 million for the three months ended June 30, 2026 and 2025, respectively.

The $2.5 million increase is the result of increased product sales of PEMGARDA due to an increase in product demand.

Cost of Product Revenue

Cost of product revenue was $1.0 million and $0.8 million for the three months ended March 31, 2026 and 2025, respectively.

Cost of product revenue was $1.3 million and $0.7 million for the three months ended June 30, 2026 and 2025, respectively.

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

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Research and Development Expenses

Three Months Ended March 31,

Three Months Ended June 30,

(in thousands)

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(3) In November 2025, we announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.

(4) In April 2026, we announced the nomination of VMS063 as a measles mAb candidate for clinical development.

Research and development expenses were $30.7 million for the three months ended March 31, 2026, compared to $10.6 million for the three months ended March 31, 2025.

(4) In April 2026, we announced the nomination of VMS063 as a measles mAb candidate for preclinical development.

Research and development expenses were $29.4 million for the three months ended June 30, 2026, compared to $9.6 million for the three months ended June 30, 2025.

The $19.8 million increase in research and development expenses was primarily due to the following:

• Decrease in direct costs related to our pemivibart program resulted from a decrease of $0.6 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.5 million in nonclinical expenses and $0.1 million in contract costs for commercial manufacturing;

• Increase in direct costs related to our VYD2311 program resulted from an increase of $21.5 million in contract research costs for our Phase 3 DECLARATION clinical trial and $0.4 million in external discovery-related and other costs, partially offset by a decrease of $0.3 million in contract costs for commercial manufacturing and $0.3 million in nonclinical expenses;

• Increase in direct costs related to our VBY329 program resulted from the nomination of VBY329 as an RSV mAb candidate in the fourth quarter of 2025, with costs resulting from nonclinical expenses;

• Increase in direct costs for our VMS063 program resulted from the nomination of VMS063 as a measles mAb candidate in the second quarter of 2026, with costs resulting from external discovery-related and other costs;

• Decrease in direct costs related to our early-stage programs resulted from a decrease of external discovery-related and other costs;

• Decrease in personnel related costs resulted from a decrease of headcount-related costs;

• Decrease in external discovery-related and other costs resulted from a decrease of $0.3 million in contract manufacturing costs and $0.1 million in nonclinical costs, partially offset by an increase of $0.2 million in clinical trial expenses and $0.1 million in other external costs.

• Decrease in direct costs related to our pemivibart program resulted from a decrease of $0.4 million in contract costs for manufacturing, $0.1 million in nonclinical expenses and $0.1 million in external discovery-related and other costs;

• Increase in direct costs related to our VYD2311 program resulted from an increase of $18.5 million in contract research costs for our Phase 3 DECLARATION and LIBERTY clinical trials, $0.5 million in external discovery-related and other costs, and $0.3 million in contract costs for manufacturing;

• Increase in direct costs related to our VBY329 program resulted from the nomination of VBY329 as an RSV mAb candidate in the fourth quarter of 2025, and consist primarily of external discovery-related costs;

• Increase in direct costs for our VMS063 program resulted from the nomination of VMS063 as a measles mAb candidate in the second quarter of 2026, and consist primarily of contract development and manufacturing costs;

• Early-stage program costs remained relatively consistent between periods;

• Increase in personnel related costs resulted from an increase in headcount-related costs;

• External discovery-related and other costs remained relatively consistent between periods.

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 $25.1 million for the three months ended March 31, 2026, compared to $16.8 million for the three months ended March 31, 2025.

Selling, general and administrative expenses were $29.5 million for the three months ended June 30, 2026, compared to $16.6 million for the three months ended June 30, 2025.

The $12.9 million increase in selling, general and administrative expenses was primarily due to the following:

• Increase in personnel related costs resulted from an increase in headcount-related costs;

• Increase in professional and consultant fees resulted from an increase of $3.4 million in professional service fees and $1.7 million related to sales and marketing costs, partially offset by a decrease of $0.1 million in insurance costs;

• Increase in other costs primarily resulted from an increase of $0.7 million in employee related travel expense, $0.3 million in conference related costs and $0.2 million in technology related costs.

• Increase in professional and consultant fees primarily resulted from an increase of $4.2 million in professional service fees and $3.5 million related to sales and marketing costs, partially offset by $0.1 million in insurance costs;

• Increase in other costs primarily resulted from an increase of $0.5 million in employee related travel expense, $0.2 million in software licensing costs and $0.2 million in rent expense.

Other Income, Net

Other income, net was $1.7 million and $0.6 million for the three months ended March 31, 2026 and 2025, respectively, consisting primarily of interest earned on our invested cash balances.

Other income, net was $1.4 million and $0.4 million for the three months ended June 30, 2026 and 2025, respectively, consisting primarily of interest earned on our invested cash balances.

The $1.0 million increase in other income, net was primarily due to an increase in cash invested.

Comparison of the six months ended June 30, 2026 and 2025

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:

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 $28.0 million and $23.1 million for the six months ended June 30, 2026 and 2025, respectively.

The $4.9 million increase is the result of increased product sales of PEMGARDA due to an increase in product demand.

Cost of Product Revenue

Cost of product revenue was $2.3 million and $1.5 million for the six months ended June 30, 2026 and 2025, respectively.

The $0.8 million increase is the result of increased PEMGARDA product sales.

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.

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)

Early-stage programs

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.

(3) In November 2025, we announced the nomination of VBY329 as an RSV mAb candidate for preclinical development.

(4) In April 2026, we announced the nomination of VMS063 as a measles mAb candidate for preclinical development.

Research and development expenses were $60.1 million for the six months ended June 30, 2026, compared to $20.2 million for the six months ended June 30, 2025.

The $39.9 million increase was primarily due to the following:

• Decrease in direct costs related to our pemivibart program resulted from decrease of $0.7 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.6 million in nonclinical costs, and $0.5 million in contract costs for commercial manufacturing;

• Increase in direct costs related to our VYD2311 program resulted from an increase of $40.0 million in contract research costs for our Phase 3 DECLARATION and LIBERTY clinical trials, $0.7 million in external discovery-related and other costs, partially offset by a decrease of $0.1 million in nonclinical costs;

• Increase in direct costs related to our VMS063 program resulted from the nomination of VMS063 as a measles mAb candidate in the second quarter of 2026, and consist primarily of contract development and manufacturing costs;

• Early-stage programs costs remained relatively consistent between periods;

• Increase in personnel related costs resulted from an increase in headcount-related costs;

• External discovery-related and other costs remained relatively consistent between periods.

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 $54.6 million for the six months ended June 30, 2026, compared to $33.3 million for the six months ended June 30, 2025.

The $21.3 million increase in selling, general and administrative expenses was primarily due to the following:

• Increase in personnel related costs resulted from an increase of $6.8 million in headcount-related costs, partially offset by a decrease in stock-based compensation costs of $0.3 million;

• Increase in professional and consultant fees resulted from an increase of $7.6 million in professional service fees and $5.2 million in sales and marketing costs, partially offset by a decrease of $0.2 million in insurance costs;

• Increase in other costs primarily resulted from an increase of $1.2 million in employee related travel costs, $0.3 million in technology related costs, $0.2 million in conference related costs, $0.2 million in rent expense, and $0.1 million in educational grant costs.

Other Income, Net

Other income, net was $3.2 million and $1.0 million for the six months ended June 30, 2026 and 2025, respectively, in each case consisting primarily of interest earned on our cash balances.

The $2.2 million increase in other income, net was primarily due to an increase in cash invested.

Liquidity and Capital Resources

Sources of Liquidity

Through March 31, 2026, 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 VYD2311, VBY329, VMS063 and our other product candidates.

As of March 31, 2026, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, $327.5 million from sales of our common stock from our IPO in August 2021, $72.7 million from sales of our common stock under the Sales Agreement (as defined below), and $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below).

Through June 30, 2026, 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 while it remains authorized and advance the development of VYD2311, VBY329, VMS063 and our other product candidates.

As of June 30, 2026, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, $327.5 million from sales of our common stock from our IPO in August 2021, $92.1 million from sales of our common stock under the Sales Agreement (as defined below), and $181.6 million from sales of our common stock and pre-funded warrants under the Underwriting Agreements (as defined below).

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

As of March 31, 2026, we had cash and cash equivalents of $184.2 million.

In April 2026, we sold 11,803,589 shares of our common stock under the Sales Agreement at an average price of $1.70 per share for $19.4 million in proceeds net of commissions.

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

On June 30, 2026, HHS provided advance notice of the termination of the declaration, which will take effect after a twelve-month transition period ending on June 29, 2027.

Consequently, the EUA for PEMGARDA is set to terminate on June 29, 2027.

We have not obtained regulatory authorization or approval for any other product candidates, and we do not expect to generate any significant revenue from the sale of other product candidates until we complete clinical development, submit regulatory filings and receive regulatory approval for such product candidates, if ever.

As of June 30, 2026, we had cash and cash equivalents of $160.1 million.

Shelf Registration Statements

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In October 2025, we filed a new shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on December 23, 2025, for the offer and sale of up to $350 million of our securities (the “2025 Shelf Registration Statement”).

As of March 31, 2026, excluding the $75 million allocated to the 2025 ATM Prospectus Supplement (as defined below), $275 million of our securities remained available for offer and sale under the 2025 Shelf Registration Statement.

As of June 30, 2026, excluding the $75 million allocated to the 2025 ATM Prospectus Supplement (as defined below), $275 million of our securities remained available for offer and sale under the 2025 Shelf Registration Statement.

Sales Agreement

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The 2025 Shelf Registration Statement was declared effective by the SEC on December 23, 2025.

As of March 31, 2026, $75.0 million remained available for sale under the 2025 ATM Prospectus Supplement.

As of June 30, 2026, $55.0 million remained available for sale under the 2025 ATM Prospectus Supplement.

Underwriting Agreements

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The price of $2.4999 per pre-funded warrant represented the $2.50 per share purchase price for the common stock less the exercise price of $0.0001 per pre-funded warrant.

The pre-funded warrants are exercisable at any time after their original issuance and will not

The pre-funded warrants are exercisable at any time after their original issuance and will not expire.

We received total net proceeds of approximately $117.2 million, after deducting underwriting discounts and commissions and offering expenses.

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

As of March 31, 2026, we had not satisfied certain financial covenants and conditions, including the net product revenue milestone required to be eligible to access proceeds from the Term Facility.

Accordingly, as of March 31, 2026, no amounts have been drawn down under the Loan Agreement.

As of June 30, 2026, we had not satisfied certain financial covenants and conditions, including the net product revenue milestone required to be eligible to access proceeds from the Term Facility.

Accordingly, as of June 30, 2026, no amounts have been drawn down under the Loan Agreement.

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)

1 unchanged sentence

Net cash used in investing activities

Net cash (used in) provided by financing activities

Effect of exchange rate changes on cash and cash equivalents

Net cash provided by financing activities

Net decrease in cash and cash equivalents

Operating Activities

During the three months ended March 31, 2026, operating activities used $41.7 million of cash, primarily due to our net loss of $41.4 million and changes in our operating assets and liabilities of $3.6 million, partially offset by non-cash charges of $3.3 million.

The changes in our operating assets and liabilities primarily consisted of a $11.6 million decrease in accounts payable, a $2.1 million increase in prepaid expenses and other current assets, a $1.0 million increase in other non-current assets, and a $0.3 million decrease in operating lease liabilities, partially offset by a $9.2 million increase in accrued expenses and a $2.2 million decrease in accounts receivable.

During the six months ended June 30, 2026, operating activities used $84.7 million of cash, primarily due to our net loss of $85.8 million and changes in our operating assets and liabilities of $5.7 million, partially offset by non-cash charges of $6.8 million.

The changes in our operating assets and liabilities primarily consisted of a $4.2 million decrease in accounts payable, a $3.7 million increase in prepaid expenses and other current assets, a $1.1 million increase in other non-current assets, and a $0.5 million decrease in operating lease liabilities, partially offset by a $2.7 million decrease in accounts receivable, a $1.0 million increase in accrued expenses and a $0.1 million decrease in inventory.

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

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.

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

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 receivable.

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

Investing Activities

Net cash used in investing activities during the three months ended March 31, 2026 consisted of $0.7 million in purchases of property and equipment.

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

Net cash used in investing activities during the six months ended June 30, 2026 consisted of $1.2 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.

Financing Activities

Net cash used in financing activities during the three months ended March 31, 2026 consisted of $0.2 million in payments for offering costs related to the Underwriting Agreement and $0.1 million in payments for offering costs related to the Sales Agreement, partially offset by $0.1 million from the issuance of common stock under our employee stock purchase plan, and $0.1 million from exercises of stock options.

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 our 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 six months ended June 30, 2026 consisted of $19.4 million from the issuance of common stock under the Sales Agreement, $0.2 million from the issuance of common stock under our employee stock purchase plan, and $0.1 million from exercises of stock options, partially offset by $0.2 million in payments for offering costs related to the Underwriting Agreements and $0.2 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 our employee stock purchase plan, offset by $0.1 million in payments for offering costs related to the Sales Agreement.

Funding Requirements

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Our funding requirements and timing and amount of our operating expenditures will depend on many factors, including:

• the revenue received from sales of PEMGARDA and any other product candidates for which we receive future regulatory authorization or approval;

• the revenue received from sales of PEMGARDA while it remains authorized and any other product candidates for which we receive future regulatory authorization or approval;

• the rate of progress in the development of our product candidates, such as VYD2311, VBY329 and VMS063;

• the scope, progress, results and costs of discovery, nonclinical studies, preclinical development, laboratory testing and clinical trials for our product candidates and associated development programs, including our REVOLUTION clinical program;

• the extent to which we develop, in-license or acquire other product candidates, intellectual property and/or technologies;

• the scope, progress, results and costs of manufacturing and validation activities associated with our current product candidates with the development and manufacturing of our future product candidates as we advance them through preclinical and clinical development;

• the scope, progress, results and costs of manufacturing and validation activities associated with our current product candidates and our future product candidates as we advance them through preclinical and clinical development;

• the number and development requirements of product candidates that we may pursue;

• the costs, timing and outcome of regulatory review of our product candidates;

• the costs, timing and outcome of regulatory review of our product candidates, including our eligibility for expedited regulatory review and approval approaches that we may pursue for our product candidates;

• our headcount growth and associated costs as we expand our research and development capabilities and build and maintain a commercial infrastructure for product candidates for which we obtain regulatory authorization or approval;

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The actual amounts we 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 March 31, 2026.

The termination fees were not probable of payment as of June 30, 2026.

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