What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2025-11-06 compared with 2025-08-14 · 106 added, 88 removed, 330 unchanged (37% of the section changed)

15 unchanged sentences

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

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

• the anticipated timing, design, progress and results of preclinical studies and clinical trials of our product candidates, including expectations regarding the DECLARATION and LIBERTY clinical trials that are part of our broader REVOLUTION clinical program, and 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;

31 unchanged sentences

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

The Phase 1/2 clinical trial was conducted in Australia and evaluated multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration.

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 system- and patient-friendly than intravenous administration.

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

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

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

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

In October 2025, we announced that the FDA cleared our Investigational New Drug (“IND”) application for VYD2311 and provided feedback to advance our REVOLUTION clinical program, which is our development program for VYD2311.

The REVOLUTION clinical program will include two

clinical trials, DECLARATION and LIBERTY.

The DECLARATION clinical trial is our BLA-enabling, Phase 3 randomized, triple-blind, placebo-controlled pivotal clinical trial to evaluate the efficacy and safety of VYD2311 for the prevention of symptomatic COVID at three months, with either a single dose or monthly doses of VYD2311, each administered via IM injection, compared to placebo.

The LIBERTY clinical trial is designed as a Phase 3, randomized, pooled-vaccine, double-blind clinical trial to evaluate head-to-head safety and tolerability and co-administration interaction of VYD2311 with approved mRNA-based COVID vaccines in adults, subject to final alignment with the FDA.

The DECLARATION and LIBERTY clinical trials are expected to begin around year-end 2025, with top-line data anticipated mid-2026.

Additional studies in the REVOLUTION clinical program may be contemplated for conduct post-approval of VYD2311, if a BLA is granted by the FDA, to further elaborate the profile of antibody prevention of COVID.

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.

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

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.

8 unchanged sentences

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 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.

In September 2024, we announced continued neutralizing activity of PEMGARDA against SARS-CoV-2 variants KP.3.1.1 and LB.1, announced attractive neutralization potency of VYD2311 against the same contemporary viruses, and 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, March 2025 and August 2025, we announced continued neutralizing activity of PEMGARDA and VYD2311 against dominant SARS-CoV-2 variants XEC, LP.8.1 and XFG, 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.

5 unchanged sentences

We are focused on antibody discovery and use of Adimab’s platform technology, while building our internal capabilities.

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, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, with net proceeds of $327.5 million from our initial public offering (“IPO”), and with net proceeds of $39.3 million from sales of our common stock under the Sales Agreement (as defined below).

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

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 September 30, 2025, 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 our initial public offering (“IPO”), net proceeds of $43.8 million from sales of our common stock under the Sales Agreement (as defined below) and net proceeds of $53.5 million from sales of our common stock and pre-funded warrants under the Underwriting Agreement (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 $30.9 million for the six months ended June 30, 2025.

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

Since our inception, we have incurred significant losses, including a net loss of $41.4 million for the nine months ended September 30, 2025.

As of September 30, 2025, we had an accumulated deficit of $943.4 million.

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

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

manufacturing activities, and commercialization efforts.

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

11 unchanged sentences

• maintain and expand a sales, marketing and distribution infrastructure to commercialize any product candidates for which we may obtain regulatory authorization or approval;

• hire and retain personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory, scientific and other personnel;

• hire and retain personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory, scientific, commercial and other personnel;

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

On March 22, 2024, we received EUA from the FDA for PEMGARDA, and as such, we will continue to incur significant commercialization expenses related to product manufacturing, marketing, sales and distribution.

As a result, we will require additional funding through a combination of contribution from revenues, equity offerings, government or private-party grants, debt financings or other capital sources, such as collaborations with other companies, strategic alliances or licensing arrangements to support our continuing operations and pursue our growth strategy.

5 unchanged sentences

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 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 future 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.

32 unchanged sentences

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, 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 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.

3 unchanged sentences

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

• 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;

• 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;

• 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;

24 unchanged sentences

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

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

legal fees relating to patent and corporate matters;

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

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

6 unchanged sentences

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

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

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

4 unchanged sentences

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

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

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

Results of Operations

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

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

Three Months Ended June 30,

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

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

Three Months Ended September 30,

(in thousands)

12 unchanged sentences

Product Revenue, Net

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

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

Product revenue, net was $13.1 million and $9.3 million for the three months ended September 30, 2025 and 2024, respectively.

The $3.8 million increase is the result of increased product sales following the launch of PEMGARDA.

Cost of Product Revenue

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

Cost of product revenue was $1.1 million and $0.8 million for the three months ended September 30, 2025 and 2024, respectively.

The $0.3 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.

3 unchanged sentences

Research and Development Expenses

Three Months Ended June 30,

Three Months Ended September 30,

(in thousands)

7 unchanged sentences

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

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

Research and development expenses were $8.0 million for the three months ended September 30, 2025, compared to $57.9 million for the three months ended September 30, 2024.

The $49.8 million decrease in research and development expenses was primarily due to the following:

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

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

• Decrease in direct costs related to our pemivibart program resulted from decrease of $2.8 million in contract research costs for our Phase 3 CANOPY clinical trial, $1.1 million in contract development and manufacturing expenses, $0.2 million in nonclinical expenses, and $0.2 million in other external costs;

• Decrease in direct costs related to our VYD2311 program resulted from decrease of $43.6 million in contract costs for commercial manufacturing, $0.7 million in contract research costs for our Phase 1/2 clinical trial, and $0.5 million in nonclinical expense;

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

2 unchanged sentences

Selling, General and Administrative Expenses

Three Months Ended June 30,

Three Months Ended September 30,

(in thousands)

2 unchanged sentences

Total selling, general and administrative expenses

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

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

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

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

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

Selling, general and administrative expenses were $15.0 million for the three months ended September 30, 2025, compared to $13.0 million for the three months ended September 30, 2024.

The $2.0 million increase in selling, general and administrative expenses was primarily due to the following:

• Increase in personnel related costs primarily related to a $2.2 million increase in headcount-related costs and $0.4 million in stock-based compensation expense;

• Decrease in professional and consultant fees resulted from decrease of $1.0 million related to sales and marketing costs and $0.2 million in insurance cost, partially offset by increase of $0.1 million in professional service fees;

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

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

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

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

Six Months Ended June 30,

• Increase in other costs primarily resulted from an increase of travel costs of $0.6 million.

Other income was $0.6 million and $1.6 million for the three months ended September 30, 2025 and 2024, respectively, in each case consisting primarily of interest earned on our invested cash balances.

Comparison of the nine months ended September 30, 2025 and 2024

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

Nine Months Ended September 30,

(in thousands)

12 unchanged sentences

Product Revenue, Net

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

Product revenue, net was $36.2 million and $11.6 million for the nine months ended September 30, 2025 and 2024, respectively.

The $24.6 million increase is the result of increased product sales following the launch of PEMGARDA in April 2024.

Cost of Product Revenue

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

Cost of product revenue was $2.6 million and $0.9 million for the nine months ended September 30, 2025 and 2024, respectively.

The $1.7 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.

3 unchanged sentences

Research and Development Expenses

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

7 unchanged sentences

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

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

Research and development expenses were $28.3 million for the nine months ended September 30, 2025, compared to $119.3 million for the nine months ended September 30, 2024.

The $91.0 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 $12.5 million in contract costs for commercial manufacturing, $11.4 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.8 million in nonclinical costs, and $0.6 million in other external costs;

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

• Decrease in direct costs related to our VYD2311 program resulted from decrease of $59.5 million in contract costs for clinical and commercial manufacturing, $1.7 million in nonclinical expense, and $0.3 million in clinical trial expense, partially offset by increase of $0.1 million in external discovery-related and other costs;

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

2 unchanged sentences

Selling, General and Administrative Expenses

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

2 unchanged sentences

Total selling, general and administrative expenses

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

Selling, general and administrative expenses were $48.4 million for the nine months ended September 30, 2025, compared to $49.0 million for the nine months ended September 30, 2024.

The $0.6 million decrease in selling, general and administrative expenses was primarily due to the following:

1 unchanged sentence

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

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

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

• Increase in other costs primarily resulted from increase of $1.6 million in travel costs and $0.2 million in software licensing costs.

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

Other income was $1.6 million and $6.2 million for the nine months ended September 30, 2025 and 2024, respectively, in each case consisting primarily of interest earned on our invested cash balances.

Liquidity and Capital Resources

Sources of Liquidity

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

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

To date, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, with aggregate net proceeds from our IPO in August 2021 of $327.5 million, and with net proceeds of $39.3 million from sales of our common stock under the Sales Agreement (as defined below).

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

As of September 30, 2025, 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, with aggregate net proceeds after deducting issuance costs of $43.8 million from sales of our common stock under the Sales Agreement (as defined below), and with net proceeds after deducting underwriting discounts and commissions and offering expenses of $53.5 million from sales of our common stock and pre-funded warrants under the Underwriting Agreement (as defined below).

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

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

As of September 30, 2025, we had cash and cash equivalents of $85.0 million.

In October 2025, we sold 18,655,402 shares of our common stock under the Sales Agreement at an average price of $1.60 per share for $28.9 million in proceeds net of commissions.

Shelf Registration Statements

In September 2022, we filed a shelf registration statement on Form S-3 with the SEC and an accompanying base prospectus, which was declared effective by the SEC on October 5, 2022, for the offer and sale of up to $400 million of our securities (the “2022 Shelf Registration Statement”).

As of September 30, 2025, $267.5 million of our securities remained available for offer and sale under the 2022 Shelf Registration Statement.

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

As of the date of this Quarterly Report on Form 10-Q, the 2025 Shelf Registration Statement has not yet been declared effective by the SEC.

However, we are permitted to continue to offer and sell, subject to applicable SEC requirements, unsold securities remaining on the 2022 Shelf Registration Statement until the 2025 Shelf Registration Statement has been declared effective (or April 3, 2026, if sooner).

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.

In December 2023, we entered into a Controlled Equity Offering SM Sales Agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co., as sales agent (“Cantor”) and filed with the SEC a prospectus supplement to the 2022 Shelf Registration Statement (the “2023 ATM Prospectus Supplement”), 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.

Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares.

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

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 after deducting issuance costs.

In August 2025, we sold 4,400,000 shares of our

common stock under the Sales Agreement at an average price of $1.05 per share for $4.5 million in proceeds net of commissions.

As of September 30, 2025, $29.9 million remained available for sale under the 2023 ATM Prospectus Supplement.

In October 2025, we sold 18,655,402 shares of our common stock under the Sales Agreement at an average price of $1.60 per share for $28.9 million in proceeds net of commissions.

In October 2025, in connection with the filing of the 2025 Shelf Registration Statement, we filed with the SEC a new prospectus supplement, pursuant to which we may, at our option, after the 2025 Registration Statement is declared effective by the SEC, 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.

Cantor is entitled to a commission of 3% of the gross proceeds from any sales of such shares.

Underwriting Agreement

In August 2025, we completed an underwritten public offering pursuant to an underwriting agreement (the “Underwriting Agreement”) with Cantor, as representative of the underwriters named therein, pursuant to which we issued and sold an aggregate of 89,234,480 shares of our common stock at a price of $0.52 per share, and pre-funded warrants to purchase up to an aggregate of 21,342,442 shares of common stock at a price of $0.5199 per pre-funded warrant.

The price of $0.5199 per pre-funded warrant represented the $0.52 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 expire.

We received total net proceeds of approximately $53.5 million, after deducting underwriting discounts and commissions and offering expenses.

Loan Agreement

2 unchanged sentences

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

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

As of September 30, 2025, we had not satisfied the net product revenue milestone required to be eligible to access proceeds from the Term Facility.

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%.

4 unchanged sentences

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

Six Months Ended June 30,

Nine Months Ended September 30,

(in thousands)

2 unchanged sentences

Net cash provided by financing activities

Net decrease in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Operating Activities

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

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

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

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

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

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

During the nine months ended September 30, 2025, operating activities used $42.7 million of cash, primarily due to our net loss of $41.4 million and changes in our operating assets and liabilities of $12.3 million, partially offset by non-cash charges

of $11.0 million.

The changes in our operating assets and liabilities primarily consisted of a $24.9 million decrease in accrued expenses, and a $1.0 million decrease in operating lease liabilities, partially offset by a $7.5 million increase in accounts payable, a $5.4 million decrease in prepaid expenses and other current assets, and a $0.7 million decrease in accounts receivable.

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

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 other current assets, 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.

Investing Activities

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

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

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

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.

Financing Activities

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

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

Net cash provided by financing activities during the nine months ended September 30, 2025 consisted of $54.0 million from the issuance of common stock and pre-funded warrants sold under the Underwriting Agreement, $4.5 million from the issuance of common stock under the Sales Agreement, $0.2 million from the issuance of common stock under the 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 Agreement and $0.1 million in payments for offering costs related to the Sales Agreement.

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, partially offset by $0.5 million in payments for offering costs related to the Sales Agreement.

Funding Requirements

Our expenses could increase in connection with our ongoing activities, particularly as we advance the nonclinical and preclinical studies and the clinical trials of our product candidates, including any associated manufacturing activities, and commercialization efforts.

Our expenses are expected to increase in connection with our ongoing activities, particularly as we advance the REVOLUTION clinical program for VYD2311, the nonclinical and preclinical studies and the clinical trials of our other product candidates, our ongoing and planned commercialization efforts, and any associated manufacturing activities in connection with our clinical development and commercialization activities.

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 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;

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

15 unchanged sentences

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 condensed 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 condensed 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 future 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.

6 unchanged sentences

Contractual Obligations and Commitments

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

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

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

As of September 30, 2025, the total remaining contractually binding commercial drug substance and drug product purchase obligations due to WuXi Biologics was $25.6 million, which was included in accounts payable and accrued expenses.

The remaining balance is expected to be paid in 2025.

Through June 30, 2025, we committed to noncancelable purchase obligations related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.

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

Through September 30, 2025, we committed to noncancelable purchase obligations related to the procurement of materials to be used in future drug substance and drug product manufacturing under the Commercial Manufacturing Agreement.

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

The remaining balance is expected to be paid in 2025.

21 unchanged sentences

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