Invivyd, Inc.
For the period ended Sep 30, 2025. Filed Nov 6, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 6, 2025
IVVD$0.56-3.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0000950170-25-109029
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-06.
0001193125-25-268076
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 197 previous paragraphs and 205 current paragraphs.
146 unchanged; 47 reworded; 10 added; 4 removed; 0 previous and 2 current paragraphs rearranged.
Tables are not compared: 7 previous and 7 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
Comparison of the nine months ended September 30, 2025 and 2024
Current report
Decrease in personnel related costs resulted from decrease of $3.4 million in headcount-related costs; and
Current report
Shelf Registration Statements
Current report
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.
Current report
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”).
Current report
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).
Current report
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.
Current report
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.
Current report
Underwriting Agreement
Current report
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.
Removed paragraphs (4)
Previous report
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.
Previous report
Comparison of the six months ended June 30, 2025 and 2024
Previous report
Decrease in personnel related costs resulted from decrease of $3.0 million in headcount-related costs; and
Previous report
the rate of progress in the development of our product candidates, such as VYD2311;
Reworded paragraphs (47)
Previous wording
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;
Current wording
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;
Previous wording
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 1/2 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 1/2 randomized, blinded, placebo-controlled clinical trial evaluated escalating dosing as well as safety, tolerability, pharmacokinetics and immunogenicity of VYD2311 in healthy trial participants. The Phase 1/2 clinical trial was conducted in Australia and evaluated multiple dose levels of VYD2311 through various routes of administration, including exploration of intramuscular administration and subcutaneous administration, which are designed to be more system- and patient-friendly than intravenous administration. In June 2025, we announced positive full Phase 1/2 clinical data for VYD2311 for both safety and pharmacokinetics. In August 2025, we announced alignment with advice from the FDA on a compact and, therefore, rapid pathway to potential BLA approval for VYD2311 for the prevention of COVID-19. As part of a recent Type C meeting, the FDA advised that a single, Phase 2/3 randomized, double-blind, placebo-controlled trial evaluating mAb efficacy from a relatively modest number of RT-PCR-confirmed symptomatic COVID-19 disease events could support a BLA submission for VYD2311 for the prevention of COVID-19 in a broad population of Americans (12 years of age and older, weighing at least 40kg), including immunocompromised people, subject to agreement on safety database size and pending full protocol review. Like pemivibart, VYD2311 was engineered from adintrevimab, our investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19.
Current wording
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 1/2 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 1/2 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 (“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 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 inv…
Excerpt shortened here; the source contains the full paragraph.
Previous wording
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.
Current wording
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, 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.
Previous wording
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. 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.
Current wording
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.
Previous wording
Since our inception, we have incurred significant losses, including a net loss of $30.9 million for the six months ended June 30, 2025. As of June 30, 2025, we had an accumulated deficit of $932.9 million. We may continue to incur significant expenses and recognize losses in the foreseeable future as we expand and progress our research and development activities, manufacturing activities and commercialization efforts. In addition, our losses from operations may fluctuate significantly from period to period depending on the timing of our clinical trials and our expenditures on other research and development activities, manufacturing activities, and commercialization efforts. Our expenses could increase substantially in connection with our ongoing activities, as we:
Current wording
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:
Previous wording
hire and retain personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory, scientific and other personnel; and
Current wording
hire and retain personnel, including research, clinical, development, manufacturing, quality control, quality assurance, regulatory, scientific, commercial and other personnel; and
Previous wording
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. See the section entitled “Liquidity and Capital Resources” for more information.
Current wording
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. See the section entitled “Liquidity and Capital Resources” for more information.
Previous wording
Research and development activities are central to our business model. 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.
Current wording
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher and more variable development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Our research and development expenses will increase as we continue advancing VYD2311 through clinical development, particularly as we advance the REVOLUTION clinical program, pursue EUA or regulatory approval of our product candidates, and continue to discover and develop additional product candidates.
Previous wording
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;
Current wording
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;
Previous wording
Product revenue, net was $23.1 million and $2.3 million for the six months ended June 30, 2025 and 2024, respectively. The $20.8 million increase is the result of increased product sales following the launch of PEMGARDA in April 2024.
Current wording
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.
Previous wording
Cost of product revenue was $0.7 million and $0.1 million for the three months ended June 30, 2025 and 2024, respectively. The $0.6 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.
Current wording
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.
Previous wording
Research and development expenses were $9.6 million for the three months ended June 30, 2025, compared to $30.3 million for the three months ended June 30, 2024. The $20.8 million decrease in research and development expenses was primarily due to the following:
Current wording
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:
Previous wording
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;
Current wording
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;
Previous wording
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;
Current wording
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;
Previous wording
Decrease in external discovery-related and other costs resulted from decrease of $0.5 million in contract development and manufacturing costs related to our pipeline candidates.
Current wording
Decrease in external discovery-related and other costs resulted from decrease of $0.3 million in contract development and manufacturing costs related to our pipeline candidates.
Previous wording
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:
Current wording
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:
Previous wording
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;
Current wording
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;
Previous wording
Decrease in professional and consultant fees resulted from decrease of $0.5 million related to sales and marketing costs and $0.1 million in insurance cost, partially offset by increase of $0.4 million in professional service fees; and
Current wording
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; and
Previous wording
Increase in other costs primarily resulted from an increase of travel costs.
Current wording
Increase in other costs primarily resulted from an increase of travel costs of $0.6 million.
Previous wording
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.
Current wording
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.
Previous wording
The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024:
Previous wording
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.
Current wording
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.
Previous wording
Cost of product revenue was $1.5 million and $0.1 million for the six months ended June 30, 2025 and 2024, respectively. The $1.4 million increase is the result of increased PEMGARDA product sales following launch and certain period costs.
Current wording
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.
Previous wording
Research and development expenses were $20.2 million for the six months ended June 30, 2025, compared to $61.5 million for the six months ended June 30, 2024. The $41.3 million decrease in research and development expenses was primarily due to the following:
Current wording
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:
Previous wording
Decrease in direct costs related to our pemivibart program resulted from decrease of $11.3 million in contract costs for commercial manufacturing, $8.6 million in contract research costs for our Phase 3 CANOPY clinical trial, $0.7 million in nonclinical costs, and $0.4 million in other external costs;
Current wording
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;
Previous wording
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;
Current wording
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;
Previous wording
Decrease in external discovery-related and other costs resulted from $0.6 million in contract development and manufacturing expense related to our pipeline candidates.
Current wording
Decrease in external discovery-related and other costs resulted from $0.9 million in contract development and manufacturing expense related to our pipeline candidates.
Previous wording
Selling, general and administrative expenses were $33.3 million for the six months ended June 30, 2025, compared to $36.0 million for the six months ended June 30, 2024. The $2.7 million decrease in selling, general and administrative expenses was primarily due to the following:
Current wording
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:
Previous wording
Decrease in personnel related costs resulted from decrease of $6.9 million in stock-based compensation expense, partially offset by increase of $2.2 million in headcount-related costs. The decrease in stock-based compensation expense was primarily due to stock-based compensation expense recognized in 2024 associated with the accelerated vesting of a portion of the outstanding stock options granted to our former Chief Executive Officer, in accordance with the terms of his employment agreement;
Current wording
Decrease in personnel related costs resulted from decrease of $6.6 million in stock-based compensation expense, partially offset by increase of $4.5 million in headcount-related costs. The decrease in stock-based compensation expense was primarily due to stock-based compensation expense recognized in 2024 associated with the accelerated vesting of a portion of the outstanding stock options granted to our former Chief Executive Officer, in accordance with the terms of his employment agreement;
Previous wording
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; and
Current wording
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; and
Previous wording
Increase in other costs primarily resulted from increase of $1.0 million in travel costs and $0.3 million in software licensing costs.
Current wording
Increase in other costs primarily resulted from increase of $1.6 million in travel costs and $0.2 million in software licensing costs.
Previous wording
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.
Current wording
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.
Previous wording
Through June 30, 2025, we have incurred significant operating losses and negative cash flows from operations. Although we received an EUA from the FDA for PEMGARDA in March 2024, we may continue to incur significant expenses and potential operating losses for the foreseeable future as we continue to commercialize PEMGARDA and advance the development of our other product candidates. To date, we have financed our operations primarily with net proceeds of $464.7 million from sales of our preferred stock, with aggregate net proceeds from our IPO in August 2021 of $327.5 million, and with net proceeds of $39.3 million from sales of our common stock under the Sales Agreement (as defined below). After receiving EUA in March 2024, we have also funded our operations from sales of PEMGARDA.
Current wording
Through September 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 VYD2311 and our other product candidates. 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.
Previous wording
As of June 30, 2025, we had cash and cash equivalents of $34.9 million.
Current wording
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.
Previous wording
In December 2023, we entered into a Controlled Equity Offering SMSales 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. 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.
Current wording
In December 2023, we entered into a Controlled Equity Offering SMSales 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.
Previous wording
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. 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.
Current wording
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. 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.
Previous wording
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.
Current wording
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.
Previous wording
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. The decrease in prepaid expenses and other current assets was primarily due to the utilization of WuXi Biologics manufacturing prepayments.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Showing the first 40 of 47 pairs. Open the source sections for the rest.
Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
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.
Current report — wording carried from elsewhere
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. As of