What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-05-15 compared with 2024-11-14 · 104 added, 173 removed, 242 unchanged (53% of the section changed)

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• our plans related to the commercialization of PEMGARDA (pemivibart), which received emergency use authorization (“EUA”) from the U.S.

Food and Drug Administration (“FDA”) in March 2024;

• our expectation that PEMGARDA will be our first monoclonal antibody (“mAb”) in a planned series of innovative mAb candidates designed to keep pace with SARS-CoV-2 viral evolution, and our plans to leverage our INVYMAB platform approach to periodically introduce new or engineered mAb candidates as the SARS-CoV-2 virus evolves over time;

• the anticipated timing, design, progress and results of preclinical studies and clinical trials of our product candidates, such as pemivibart and VYD2311, 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 commitment to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2, and our aim to develop a continuous repertoire of SARS-CoV-2 neutralizing mAbs to keep pace with viral evolution;

• our expectations related to 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;

• our plans regarding submission of any applications for regulatory authorization or approval of our product candidates, including our July 2024 submission of 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 utilizing a rapid immunobridging pathway, and our expectations regarding potential scope and timing thereof;

• our expectations regarding our ability to obtain and maintain regulatory authorizations or approvals for, our product candidates;

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

• the design of PEMGARDA to keep pace with SARS-CoV-2 viral evolution;

• 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;

• 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 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;

• our discovery efforts to assess pipeline expansion beyond SARS-CoV-2, including potential targets such as respiratory syncytial virus and measles;

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

• our expectations regarding the size of the patient populations, market acceptance and opportunity for and clinical utility of our product candidates, if authorized or approved for commercial use;

• our manufacturing capabilities and strategy;

• our manufacturing capabilities and strategy, and our expectations regarding supply and demand of our product candidates;

• our ability to successfully commercialize our product candidates, if authorized or approved, including our distribution capabilities and strategy;

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

• our expectation to apply our INVYMAB platform approach to produce lead molecules for other viral diseases, such as influenza;

• our ability to identify and develop future product candidates;

• 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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is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2.

Our 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.

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

On March 22, 2024, we 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, we 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 our 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 our 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, we anticipate leveraging our 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, we nominated VYD2311, a next generation mAb candidate for COVID-19, as a drug candidate, and in September 2024, we 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.

We expect preliminary data readouts from the Phase 1 clinical trial late in the fourth quarter of 2024 and anticipate 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, 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.

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 May 2024, we 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 us with the opportunity to rapidly, efficiently, and durably deliver high value medicines that prevent and treat symptomatic COVID-19 in vulnerable

In addition to developing candidates for COVID-19, we expect to apply our INVYMAB platform approach to produce lead molecules for other viral diseases, such as influenza.

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 over four years in the COVID-19 space, we aim to develop a continuous repertoire of SARS-CoV-2 neutralizing mAbs to keep pace with viral evolution.

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.

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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We engage in active SARS-CoV-2 variant monitoring of antiviral activity as part of our ongoing industrial virology effort, which leverages a consistent, high-quality, independent, third-party pseudoviral system that routinely tests authentic Invivyd-produced molecules and is supported by structure-based analytics.

In September 2024, we announced continued neutralizing activity of PEMGARDA (pemivibart) against SARS-CoV-2 variants KP.3.1.1 and LB.1, and attractive neutralization potency of VYD2311 against the same contemporary viruses, and also provided an update to ongoing structural analysis showing no meaningful mutational change in the pemivibart binding site since the Omicron shift late in 2021.

In September 2024, we announced continued neutralizing activity of PEMGARDA against SARS-CoV-2 variants KP.3.1.1 and LB.1, and attractive neutralization potency of VYD2311 against the same contemporary viruses, and also provided an update to ongoing structural analysis showing no meaningful mutational change in the pemivibart binding site since the Omicron shift late in 2021.

In January 2025 and March 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XEC and LP.8.1, respectively.

Since our inception, we have devoted substantially all of our resources to organizing and staffing, building an intellectual property portfolio, business planning, conducting research and development, establishing and executing arrangements with third parties for the manufacture of our product candidates, and raising capital.

Our focus in recent months has been and will continue to be supporting the commercialization of PEMGARDA and establishing streamlined development pathways that could enable us to efficiently introduce new or engineered mAb candidates targeting SARS-CoV-2, leveraging our INVYMAB platform approach and previously generated safety and efficacy data from our clinical trials of adintrevimab and/or pemivibart, including pursuit of a potential EUA for COVID-19 treatment in certain immunocompromised people utilizing a rapid immunobridging pathway.

Our recent focus has been and will continue to be supporting the commercialization of PEMGARDA, advancing VYD2311 as our next generation mAb candidate for COVID-19, and establishing streamlined development pathways that could enable us to efficiently introduce new mAb candidates targeting SARS-CoV-2, leveraging previously generated safety and efficacy data from our clinical trials of adintrevimab and/or pemivibart.

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

We rely on partnerships, external consultants and contract research organizations (“CROs”) to conduct discovery, nonclinical, preclinical, clinical and commercial activities.

Additionally, we rely on contract testing laboratories and a contract development and manufacturing organization (“CDMO”) to execute our chemistry, manufacturing and controls development, testing and manufacturing activities.

We have engaged WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”), a CDMO, for the development and manufacture of our product candidates for clinical and commercial use.

Additionally, we rely on contract testing laboratories and a contract development and manufacturing organization (“CDMO”), WuXi Biologics (Hong Kong) Limited (“WuXi Biologics”), to execute our chemistry, manufacturing and controls development, testing and clinical and commercial manufacturing activities.

Further, in 2022, we secured dedicated laboratory space and expanded our research team in order to enable internal discovery and development of our mAb candidates, while continuing to leverage our existing partnership with Adimab, LLC (“Adimab”).

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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 $151.5 million for the nine months ended September 30, 2024.

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

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.

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:

• commercialize PEMGARDA;

• continue to commercialize PEMGARDA;

• advance the development of VYD2311;

• initiate and conduct clinical trials of our product candidates;

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

Based on current operating plans and excluding any contribution from future revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance date of the interim condensed consolidated financial statements in this Quarterly Report on Form 10-Q, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.

Based on current operating plans and excluding any contribution from future revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance date of the condensed consolidated financial statements in this Quarterly Report on Form 10-Q, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.

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

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

Product revenue, net consists of product revenue earned on the sales of PEMGARDA in the United States.

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

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 to advance PEMGARDA and as we expect to continue advancing VYD2311 through clinical development, including the associated manufacturing activities, 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, pursue EUA or 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.

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• the number and scope of preclinical and clinical programs we decide to pursue;

• filing acceptable IND applications with the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;

• filing acceptable Investigational New Drug applications with the FDA or comparable foreign applications that allow commencement of our planned clinical trials or future clinical trials for our product candidates;

• sufficiency of our financial and other resources to complete the necessary preclinical studies and clinical trials, manufacture the product candidates and complete associated regulatory activities;

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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.

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

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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.

In June 2022, and subsequently amended in September 2022 and August 2024, we entered into a lease agreement for dedicated laboratory and office space in Newton, Massachusetts for research and development purposes.

Through September 30, 2024, we have operated as a hybrid company with employees working at our corporate headquarters and remotely.

Through March 31, 2025, 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 September 30, 2024, various countries have enacted aspects of Pillar Two while committing to enact additional aspects in future years.

As of March 31, 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 September 30, 2024 and 2023

The following table summarizes our results of operations for the three months ended September 30, 2024 and 2023:

Three Months Ended September 30,

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,

(in thousands)

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Research and development

Acquired in-process research and development

Selling, general and administrative

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Product Revenue, Net

Product revenue, net was $9.3 million for the three months ended September 30, 2024.

There was no product revenue, net for the three months ended September 30, 2023.

The $9.3 million increase is the result of product sales in the third quarter of 2024 following the launch of PEMGARDA.

Cost of Product Revenue

Cost of product revenue was $0.8 million for the three months ended September 30, 2024.

There was no cost of product revenue for the three months ended September 30, 2023.

The $0.8 million increase is the result of 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.

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

Three Months Ended September 30,

(in thousands)

Direct, external research and development expenses by program:

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 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 $57.9 million for the three months ended September 30, 2024, compared to $25.6 million for the three months ended September 30, 2023.

The $32.3 million increase in research and development expenses was primarily due to the following:

• the decrease in direct costs related to our VYD222 program resulted from $4.3 million in contract costs for commercial manufacturing, $3.5 million in contract research costs for our CANOPY clinical trial, and $0.2 million in nonclinical expenses, partially offset by increases of $0.3 million in other external expenses;

• the increase in direct costs related to our VYD2311 program resulted from the nomination of our VYD2311 product candidate in the first quarter of 2024 and consisted primarily of contract manufacturing costs;

• the direct costs related to our adintrevimab program were consistent following the nomination of our VYD222 product candidate in the first quarter of 2023;

• the decrease in personnel related costs related to a $1.8 million decrease in stock-based compensation and the capitalization of certain inventory costs which were recorded as research and development personnel related costs prior to the EUA of PEMGARDA;

• the decrease in external discovery-related and other costs resulted from a $1.9 million decrease in contract manufacturing costs and $0.9 million decrease in other nonclinical expenses, partially offset by a $1.2 million increase in other external costs related to our pipeline candidates.

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

There was no IPR&D expense recognized during the three months ended September 30, 2024.

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

Selling, General and Administrative Expenses

Three Months Ended September 30,

(in thousands)

Personnel related (including stock-based compensation)

Professional and consultant fees

Total selling, general and administrative expenses

Selling, general and administrative expenses were $13.0 million for the three months ended September 30, 2024, compared to $12.9 million for the three months ended September 30, 2023.

The $0.1 million increase in selling, general and administrative expenses was primarily due to the following:

• the decrease in personnel related costs was primarily due to decreases in headcount and stock-based compensation;

• the increase in professional and consultant fees was primarily due to a $3.7 million increase related to the commercialization of PEMGARDA, partially offset by a $1.4 million and $0.3 million decrease in professional service fees and director and officer insurance premiums, respectively;

• other costs remained relatively consistent between periods.

Other income was $1.6 million for the three months ended September 30, 2024, consisting primarily of interest earned on our invested cash balances.

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

Comparison of the nine months ended September 30, 2024 and 2023

The following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:

Nine Months Ended September 30,

(in thousands)

Product revenue, net

Total revenue

Operating costs and expenses:

Cost of product revenue

Research and development

Acquired in-process research and development

Selling, general and administrative

Total operating costs and expenses

Loss from operations

Other income (expense):

Other income (expense), net

Total other income (expense), net

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

Product Revenue, Net

Product revenue, net was $11.6 million for the nine months ended September 30, 2024.

There was no product revenue, net for the nine months ended September 30, 2023.

The $11.6 million increase is the result of product sales following the launch of PEMGARDA in the second quarter of 2024.

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.

Cost of Product Revenue

Cost of product revenue was $0.9 million for the nine months ended September 30, 2024.

There was no cost of product revenue for the nine months ended September 30, 2023.

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.

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Research and Development Expenses

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

Direct, external research and development expenses by program:

Pemivibart (1)

Unallocated research and development expenses:

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Total research and development expenses

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

(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 $119.3 million for the nine months ended September 30, 2024, compared to $96.4 million for the nine months ended September 30, 2023.

The $22.9 million increase in research and development expenses was primarily due to the following:

• the decrease in direct costs related to our VYD222 program resulted from $26.5 million in contract costs for commercial manufacturing and $0.5 million in nonclinical expenses, partially offset by increases of $1.8 million in contract research costs for our CANOPY clinical trial and $0.5 million in other external expenses;

• the decrease in direct costs related to our adintrevimab program of $2.9 million resulted from the nomination of our VYD222 product candidate in the first quarter of 2023;

• the decrease in personnel related costs related to capitalization of $4.0 million of certain inventory costs which were recorded as research and development costs prior to the EUA of PEMGARDA and a $2.6 million decrease primarily due to a reduction in headcount, including a $0.7 million decrease due to stock-based compensation;

• the decrease in external discovery-related and other costs resulted from a $5.1 million decrease in contract manufacturing costs related to our pipeline candidates and a $2.7 million decrease in other nonclinical expenses, partially offset by a $0.6 million increase in other external costs and $0.2 million in clinical trial expenses.

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

There was no IPR&D expense recognized during the nine months ended September 30, 2024.

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

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.

The $20.5 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 personnel related costs resulted from decrease of $2.7 million in headcount-related costs.

Selling, General and Administrative Expenses

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

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Total selling, general and administrative expenses

Selling, general and administrative expenses were $49.0 million for the nine months ended September 30, 2024, compared to $34.0 million for the nine months ended September 30, 2023.

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:

• the increase in personnel related costs was primarily due to an increase in headcount-related costs, including an increase in stock-based compensation expense of $4.0 million that was primarily due to 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;

• the increase in professional and consultant fees and other costs of $8.2 million and 0.7 million, respectively, was primarily related to the commercialization of PEMGARDA.

Other income was $6.2 million for the nine months ended September 30, 2024, consisting primarily of interest earned on our invested cash balances.

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

• 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;

• Increase in other costs primarily resulted from increase of $0.5 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.

Liquidity and Capital Resources

Sources of Liquidity

Through September 30, 2024, 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 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).

Through March 31, 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.

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.

Sales Agreement

In December 2023, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”), pursuant to which we may, at our option, offer and sell shares of our 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, 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 September 30, 2024, $34.5 million remained available for sale under the Sales Agreement.

As of September 30, 2024, we had cash and cash equivalents of $106.9 million.

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

Loan Agreement

On April 18, 2025, we 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”), we are 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, we 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 we have requested and the Lender has funded any loans under the Term Facility prior to such date.

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

Nine Months Ended September 30,

Three Months Ended March 31,

(in thousands)

Net cash used in operating activities

Net cash (used in) provided by investing activities

Net cash used in investing activities

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

Operating Activities

During the nine months ended September 30, 2024, operating activities used $132.9 million of cash, primarily due to our net loss of $151.5 million, partially offset by non-cash charges of $18.3 million and changes in our operating assets and liabilities of $0.3 million.

The changes in our operating assets and liabilities primarily consisted of a $16.0 million increase in accrued expenses, a $15.3 million decrease in prepaid expenses, and a $9.7 million increase in accounts payable, partially offset by a $23.4 million increase in inventory, a $8.1 million increase in accounts receivables, a $7.3 million increase in other non-current assets, a $1.2 million decrease in operating lease liabilities and a $0.7 million decrease in other non-current liabilities.

The increase in 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.

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

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

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

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 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.

Investing Activities

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

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

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

Financing Activities

Net cash provided by financing activities during the nine months ended September 30, 2024 consisted of $39.3 million from the issuance of common stock under the Sales Agreement, $0.3 million from exercises of stock options, and $0.2 million from the issuance of common stock under the employee stock purchase plan, offset by $0.5 million in payments for offering costs related to the Sales Agreement.

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

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.

Funding Requirements

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• the revenue received from sales of PEMGARDA 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;

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

• 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;

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• the costs, timing and outcome of regulatory review of 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;

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

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

• the timing and costs of securing sufficient manufacturing capacity for clinical and commercial supply of our product candidates, or the raw material components thereof, as needed in the future;

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

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• the continuation of our existing licensing and collaboration arrangements and entry into new collaborations and licensing arrangements, if at all;

• the need and ability to hire and retain additional research, clinical, development, scientific and manufacturing personnel;

• the costs we incur in maintaining business operations;

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Substantial Doubt about Ability to Continue as a Going Concern

In accordance with Accounting Standards Update 2014-15, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern (Subtopic 205-40), we are required to evaluate whether there are conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern from the issuance date of our consolidated financial statements.

Based on current operating plans and excluding any contribution from future revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance of these consolidated financial statements, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.

Based on current operating plans and excluding any contribution from future revenues or external financing, we will not have sufficient cash and cash equivalents to fund our operating expenses and capital requirements beyond one year from the issuance of these condensed consolidated financial statements, and therefore, we have concluded that there is substantial doubt about our ability to continue as a going concern.

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

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Debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making acquisitions or capital expenditures or declaring dividends.

Such restrictions could adversely impact our ability to conduct our operations and execute our business plan.

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

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Contractual Obligations and Commitments

Through September 30, 2024, 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 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.

Through September 30, 2024, we committed to noncancelable purchase obligations of $17.0 million related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement, which is expected to be paid in 2024.

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.

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

Other than the above noted transactions, during the three and nine months ended September 30, 2024, there were no material changes to our contractual obligations from those described in the 2023 Form 10-K.

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.

Critical Accounting Policies and Significant Judgments and Estimates

Our financial statements are prepared in accordance with generally accepted accounting principles in the United States.

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

Our financial statements are prepared in accordance with generally accepted accounting principles in the U.S.

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

Our critical accounting policies and estimates are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Policies and Significant Judgments and Estimates” in the 2024 Form 10-K.

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Emerging Growth Company Status

We are an “emerging growth company,” as defined in 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 our IPO.

However, if certain events occur prior to the end of such five-year period, including if we become a “large accelerated filer,” our annual gross revenues exceed $1.235 billion or we issue more than $1.0 billion of non-convertible debt in the previous three-year period, we will cease to be an emerging growth company prior to the end of such five-year period.

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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