Invivyd (NASDAQ: IVVD) doubles 2025 revenue and advances COVID-19 antibody
Rhea-AI Filing Summary
Invivyd, Inc. reported strong 2025 growth as net product revenue rose to
PEMGARDA quarterly net product revenue reached
Positive
- Revenue growth and margin improvement: 2025 net product revenue increased to $53.4M from $25.4M, while loss from operations shrank to $55.6M from $176.9M, reflecting stronger PEMGARDA sales and significantly lower research and development spending.
- Strengthened balance sheet: Cash and cash equivalents rose to $226.7M from $69.3M, supported by more than $200M raised in the second half of 2025, enhancing Invivyd’s ability to fund pivotal trials and commercialization plans.
- Advancing late-stage pipeline: The Phase 3 DECLARATION trial of COVID-19 antibody VYD2311 is fully enrolled, has Fast Track designation, and is expected to deliver top-line data mid-year, while RSV candidate VBY329 and Long COVID initiatives expand the development portfolio.
Negative
- None.
Insights
Invivyd showed rapid revenue growth, tighter spending, stronger cash, and advancing COVID-19 antibody programs.
Invivyd more than doubled 2025 net product revenue to
Cash and cash equivalents grew to
Strategically, the fully enrolled Phase 3 DECLARATION trial for VYD2311, with Fast Track designation and expected mid-year top-line data, is a key 2026 milestone. Additional programs, including the LIBERTY trial concept, RSV antibody VBY329, and the SPEAR Long COVID effort, broaden the pipeline, but actual outcomes will depend on future clinical results and regulatory interactions.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| Item 2.02. | Results of Operations and Financial Condition. |
On March 5, 2026, Invivyd, Inc. (the “Company”) issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2025, and recent business highlights. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 2.02.
The information furnished pursuant to this Item 2.02, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed to be incorporated by reference into any of the Company’s filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.
| Item 8.01. | Other Events. |
On March 5, 2026, the Company posted an updated corporate presentation on its website at www.invivyd.com. A copy of the presentation is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated March 5, 2026 | |
| 99.2 | Corporate Presentation, dated March 5, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| INVIVYD, INC. | ||||||
| Date: March 5, 2026 | By: | /s/ Jill Andersen | ||||
| Jill Andersen | ||||||
| Chief Legal Officer and Corporate Secretary | ||||||
Exhibit 99.1
Invivyd Reports Fourth Quarter and Full-Year 2025 Financial Results and Provides Recent Business Highlights and DECLARATION Clinical Trial Updates
| • | Achieved Q4 2025 PEMGARDA® (pemivibart) net product revenue of $17.2 million, representing 25% growth year-over-year and 31% growth quarter-over-quarter |
| • | 2025 year-end cash and cash equivalents of $226.7 million after raising over $200 million from financing transactions in 2H 2025 |
| • | Announced initiation of DECLARATION Phase 3 pivotal clinical trial of vaccine-alternative antibody VYD2311 to prevent COVID, with top-line data expected mid-2026; Fast Track designation for VYD2311 granted by FDA in December 2025 |
| • | DECLARATION trial on track with full enrollment achieved |
| • | DECLARATION trial Independent Data Monitoring Committee (IDMC) prespecified review of unblinded VYD2311 safety data resulted in IDMC recommendation to allow enrollment of pregnant and breastfeeding women in the DECLARATION trial |
| • | DECLARATION trial blinded, pooled early COVID event accumulation appears on track; any potential re-sizing decision to depend on trial progress but could occur in approximately April |
| • | Distinguished scientist and physician Michael Mina, M.D., Ph.D., appointed Chief Medical Officer |
| • | Management to host conference call today at 8:30AM ET |
NEW HAVEN, Conn., Mar. 05, 2026 (GLOBE NEWSWIRE) — Invivyd, Inc. (Nasdaq: IVVD) today announced financial results for the fourth quarter and full year ended December 31, 2025, and recent business highlights.
“With potential commercialization of VYD2311 on the horizon, we are encouraged by continued commercial execution and appeal for monoclonal antibody prophylaxis demonstrated by revenue of PEMGARDA® (pemivibart) more than doubling year over year, while operating expenses were reduced by nearly half,” noted Bill Duke, Chief Financial Officer of Invivyd. “While we are pleased with Invivyd’s ability to exhibit financial discipline, we are most excited about the positive momentum behind VYD2311 and that our recent capital raises enable us to invest in the ongoing DECLARATION pivotal clinical trial and potential commercialization, if approved, in addition to our other pipeline programs.”
“2026 is off to a busy start as we execute our pivotal VYD2311 program, expand our pipeline of monoclonal antibodies, and educate key stakeholders about the role monoclonal antibodies can and should play in the prevention of critical infectious diseases, beginning with COVID,” commented Marc Elia, Chairman of the Invivyd Board of Directors. “We are pleased with the progress we’ve made and remain focused on creating medical value for patients and shareholders with molecules that can complement, provide alternative to, or synergize with vaccination across multiple pathogens. We look forward to sharing additional updates throughout the year.”
Recent Business Highlights
| • | Clinical & Regulatory Developments |
| • | Following trial initiation in late 2025, the DECLARATION pivotal clinical trial recruitment has progressed rapidly with full enrollment achieved. |
| • | The Independent Data Monitoring Committee (IDMC), responsible for monitoring safety in the DECLARATION trial, recently completed its prespecified review of unblinded safety data at an early timepoint, as defined in the protocol, for VYD2311 in the DECLARATION trial and returned the following recommendations: |
| • | Pregnant and breastfeeding women are now eligible to participate in the study and may enroll. |
| • | Women of childbearing age are no longer required to use contraception. |
| • | Further pre-existing protocol-specified safety visits and evaluations at Day 8, Day 38, and Day 68 are no longer required. |
| • | Early blinded, pooled COVID events in the DECLARATION trial are beginning to accumulate and suggest overall trial progress is on track; any potential trial up-sizing decision to support statistical power will be based on overall progress and COVID event rate using prespecified criteria, and could be decided upon in approximately April. |
| • | In February 2026, Invivyd announced it received and was aligned with advice from the U.S. Food and Drug Administration (FDA) on the LIBERTY Phase 3 clinical trial, which will assess the safety and immunologic profile of VYD2311, the company’s vaccine-alternative monoclonal antibody investigational candidate for the prevention of COVID-19, versus commercially available mRNA COVID vaccines. |
| • | LIBERTY is part of the company’s broader REVOLUTION clinical program designed to elaborate the profile of monoclonal antibody-mediated prophylaxis from COVID-19 and the potential medical benefits to vulnerable Americans. |
| • | The LIBERTY clinical trial will evaluate comparative safety and immunology of VYD2311 versus mRNA COVID vaccine, as well as explore the safety and immunology of co-administered VYD2311 and mRNA COVID vaccine. |
| • | The FDA, providing feedback jointly from CDER and CBER, requested specific monitoring of adverse events of special interest relevant to mRNA COVID vaccines, citing the known risk of myocarditis/pericarditis in the young adult population following mRNA COVID vaccination; no similar requests have been made for other Invivyd clinical trials without an mRNA COVID vaccine arm. |
| • | In January 2026, Invivyd and the SPEAR (Spike Protein Elimination and Recovery) Study Group announced the plan to initiate a Phase 2 clinical trial evaluating VYD2311 in individuals with Long COVID or COVID vaccine injury. The Phase 2 clinical trial is expected to be initiated by mid-2026. |
| • | In December 2025, Invivyd announced the initiation of its DECLARATION clinical trial. |
| • | DECLARATION is a Phase 3, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of VYD2311 in the prevention of COVID versus placebo, at three months, from a single intramuscular (IM) dose. |
| • | A second arm will evaluate monthly IM doses versus placebo to demonstrate the safety and efficacy of more frequent dosing to support individual choice should at-risk persons seek periodic extra protection from COVID. |
| • | The primary endpoint of DECLARATION is the reduction of PCR-confirmed symptomatic COVID incidence versus placebo; total expected enrollment of 1770 people across all three arms. |
| • | DECLARATION is part of Invivyd’s REVOLUTION clinical program aimed at establishing monoclonal antibody prophylaxis for prevention of COVID; top-line data are expected mid-2026. |
| • | In the Phase 1/2 clinical trial, IM administered VYD2311, at 4 times the planned dose in DECLARATION, was well tolerated, with all adverse events (AEs) considered mild to moderate in severity with no serious or severe AEs reported; all AEs, including headache and injection site pain, were deemed unrelated to study drug. |
| • | In December 2025, Invivyd announced that the FDA granted Fast Track designation for VYD2311. |
| • | Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track designation can become eligible for priority review and rolling Biologics License Application (BLA) submission, which can reduce the timelines associated with regulatory action. |
| • | VYD2311 was granted Fast Track designation by the FDA for the prevention of COVID in individuals with underlying risk factors for severe COVID. |
| • | Pipeline Expansion |
| • | In November 2025, Invivyd announced selection of a potential best-in-class Respiratory Syncytial Virus (RSV) antibody candidate VBY329. |
| • | VBY329 is designed for the prevention of RSV infections in newborns, infants, and children, and results from Invivyd’s proprietary antibody discovery platform. |
| • | VBY329 meets Invivyd’s target profile of higher potency and improved barrier to resistance compared to standard of care RSV medicines, as assessed in vitro. |
| • | Invivyd expects to advance VBY329 toward IND readiness in 2H 2026 for development in pediatric RSV prophylaxis, a blockbuster pharmaceutical market in 2024, expected to grow to $3-$4 billion in annual revenues globally by 2030. |
| • | Invivyd has initiated discovery efforts to assess pipeline expansion beyond SARS-CoV-2 and RSV, and anticipates providing an update on selection of a preclinical measles monoclonal antibody candidate in the first half of 2026. |
| • | Corporate Updates |
| • | As announced earlier today, distinguished scientist and physician Michael Mina, M.D., Ph.D., appointed Chief Medical Officer |
| • | In January 2026, Invivyd announced its partnership with renowned ski champion Lindsey Vonn to elevate public understanding of antibodies, one of the most important parts of the immune system, and their role in preventing disease. A national multimedia educational campaign is planned to launch in early Spring 2026. |
| • | Fourth Quarter and Full-Year 2025 Financial Results |
| • | Revenue: Reported full year 2025 net product revenue of PEMGARDA of $53.4 million, compared to $25.4 million in 2024, with PEMGARDA net revenues commencing in Q2 2024. Reported $17.2 million of net product revenue of PEMGARDA in Q4 2025, representing a 25% increase over Q4 2024 net product revenue of $13.8 million and a 31% increase over Q3 2025 net product revenue of $13.1 million. |
| • | Cash Position: Cash and cash equivalents were $226.7 million as of December 31, 2025. In the second half of 2025, Invivyd secured over $200 million of capital. |
| • | Invivyd’s current cash and cash equivalents are anticipated to be sufficient to support the DECLARATION pivotal clinical trial, commercial preparedness for the potential launch of VYD2311, continued research and development related to its pipeline programs such as RSV and measles, continued advancement of the SPEAR Study Group efforts related to assessing the effects of monoclonal antibody therapy for Long COVID and COVID-19 Post-Vaccination Syndrome, and for working capital and other general corporate purposes. |
| • | Research & Development (R&D) Expenses: R&D expenses were $38.3 million for the year ended December 31, 2025, compared to $137.3 million for the comparable period in 2024. This decrease is primarily attributable to lower contract research costs associated with the Phase 3 CANOPY clinical trial for pemivibart, and a decrease in VYD2311 and pemivibart manufacturing costs. |
| • | Selling, General & Administrative (SG&A) Expenses: SG&A expenses were $66.9 million for the year ended December 31, 2025, compared to $63.4 million for the comparable period in 2024. This increase is primarily attributable to an increase in personnel-related costs. |
| • | Net Loss and Net Loss per Share: Net loss was $52.5 million for the year ended December 31, 2025, compared to $169.9 million for the comparable period in 2024. Basic and diluted net loss per share was $0.30 for the year ended December 31, 2025, compared to $1.43 for the comparable period in 2024. |
| • | Total shares of common stock outstanding as of December 31, 2025 were 281,987,033, excluding pre-funded warrants totaling 27,342,442 which were included in shares outstanding utilized to calculate net loss per share. |
Conference Call & Webcast
Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.
About PEMGARDA
PEMGARDA® (pemivibart) is a half-life extended investigational monoclonal antibody (mAb). PEMGARDA was engineered from adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and provided evidence of clinical efficacy in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19. PEMGARDA has demonstrated in vitro neutralizing activity against major SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1 and XFG. PEMGARDA targets the SARS-CoV-2 spike protein receptor binding domain (RBD), thereby inhibiting virus attachment to the human ACE2 receptor on host cells.
PEMGARDA (pemivibart) injection (4500 mg), for intravenous use is an investigational mAb that has not been approved, but has been authorized for emergency use by the U.S. FDA under an EUA 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.
PEMGARDA is not authorized for use for the treatment of COVID-19, Long COVID, or COVID-19 Post-Vaccination Syndrome, or for post-exposure prophylaxis of COVID-19. Pre-exposure prophylaxis with PEMGARDA is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended. Individuals for whom COVID-19 vaccination is recommended, including individuals with moderate-to-severe immune compromise who may derive benefit from COVID-19 vaccinations, should receive COVID-19 vaccination. In individuals who have recently received a COVID-19 vaccine, PEMGARDA should be administered at least 2 weeks after vaccination.
Anaphylaxis has been observed with PEMGARDA and the PEMGARDA Fact Sheet for Healthcare Providers includes a boxed warning for anaphylaxis. The most common adverse reactions included systemic infusion-related reactions and hypersensitivity reactions, local infusion site reactions, and infusion site infiltration or extravasation. For additional information, please see the PEMGARDA full product Fact Sheet for Healthcare Providers, including important safety information and boxed warning.
To support the EUA for PEMGARDA, an immunobridging approach was used to determine if PEMGARDA may be effective for pre-exposure prophylaxis of COVID-19. Immunobridging is based on the serum virus neutralizing titer-efficacy relationships identified with other neutralizing human mAbs against SARS-CoV-2. This includes adintrevimab, the parent mAb of pemivibart, and other mAbs that were previously authorized for EUA. There are limitations of the data supporting the benefits of PEMGARDA. Evidence of clinical efficacy for other neutralizing human mAbs against SARS-CoV-2 was based on different populations and SARS-CoV-2 variants that are no longer circulating. Further, the variability associated with cell-based EC50 value determinations, along with limitations related to pharmacokinetic data and efficacy estimates for the mAbs in prior clinical trials, impact the ability to precisely estimate protective titer ranges. Additionally, certain SARS-CoV-2 viral variants may emerge that have substantially reduced susceptibility to PEMGARDA, and PEMGARDA may not be effective at preventing COVID-19 caused by these SARS-CoV-2 viral variants.
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, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner. PEMGARDA is authorized for use only when the combined national frequency of variants with substantially reduced susceptibility to PEMGARDA is less than or equal to 90%, based on available information including variant susceptibility to PEMGARDA and national variant frequencies.
About VYD2311
VYD2311 is a novel monoclonal antibody (mAb) candidate being developed for COVID-19 to continue to address the urgent need for new prophylactic and therapeutic options. The pharmacokinetic profile and antiviral potency of VYD2311 may offer the ability to deliver clinically meaningful titer levels through more patient-friendly means such as an intramuscular route of administration.
VYD2311 was engineered using Invivyd’s proprietary integrated technology platform and is the product of serial molecular evolution designed to generate an antibody optimized for neutralizing contemporary virus lineages. VYD2311 leverages the same antibody backbone as pemivibart, Invivyd’s investigational mAb granted emergency use authorization in the U.S. for the pre-exposure prophylaxis (PrEP) of symptomatic COVID-19 in certain immunocompromised patients, and adintrevimab, Invivyd’s investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for the prevention and treatment of COVID-19.
About DECLARATION
DECLARATION (NCT07298434) is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular (IM) injection, compared to placebo. Total enrollment of the trial is expected to be 1770 participants.
About LIBERTY
LIBERTY is a Phase 3, randomized, double-blind clinical trial to evaluate the safety, serum virus neutralizing antibody responses, and pharmacokinetics of VYD2311, an mRNA COVID vaccine, and co-administered VYD2311 with an mRNA COVID vaccine. Total enrollment of the trial is expected to be about 210 participants.
About VBY329
VBY329 is a novel, potential best-in-class monoclonal antibody (mAb) candidate being developed to prevent Respiratory Syncytial Virus (RSV) among neonates, infants, and children.
About SPEAR Study Group
Invivyd and leading researchers formed the SPEAR (Spike Protein Elimination and Recovery) Study Group to assess the effects of monoclonal antibody (mAb) therapy for Long COVID and COVID-19 Post-Vaccination Syndrome.
About Invivyd
Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Invivyd deploys a proprietary integrated technology platform unique in the industry designed to assess, monitor, develop, and adapt to create best in class antibodies. In March 2024, Invivyd received emergency use authorization (EUA) from the U.S. FDA for a monoclonal antibody (mAb) in its pipeline of innovative antibody candidates. Visit https://invivyd.com/ to learn more.
Trademarks are the property of their respective owners.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “anticipates,” “believes,” “could,” “expects,” “estimates,” “intends,” “plans,” “potential,” “predicts,” “projects,” “future,” and “target” or similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements include statements concerning, among other things, plans related to the company’s research and development activities, and the timing and potential results thereof; expectations regarding the company’s clinical trial designs, enrollment, event accumulation and progress, regulatory pathway, product profile, indication, and administration paradigm for VYD2311, including the company’s REVOLUTION clinical program and the timing of results related thereto, as well as preparations for the potential commercial launch of VYD2311, if approved; the potential benefits of Fast Track designation; expectations regarding the COVID landscape; the potential of PEMGARDA as a mAb for pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised persons; the potential of VYD2311 as a novel mAb candidate that may be able to deliver clinically meaningful titer levels through more patient-friendly means; the company’s devotion to delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2; pipeline expansion beyond SARS-CoV-2, including potential targets such as RSV and measles, and expected announcements related thereto; the potential of VBY329 as a novel, potential best-in-class RSV mAb candidate; expectations regarding the company’s partnership with Lindsey Vonn and plans for an educational campaign to elevate public understanding of antibodies and their role in disease protection, including the timing thereof; the company’s business strategies and objectives, and ability to execute on them, including with respect to the sufficiency of its current cash and cash equivalents; expectations about the market size and opportunity for the company’s product candidates; the company’s expectation to create medical and shareholder value; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: uncertainties regarding the company’s expectations, projections and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; uncertainties regarding market acceptance, payor coverage and reimbursement, or future revenue generated by any authorized or approved product; how long the EUA granted by the FDA for PEMGARDA will remain in effect and whether such EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; the success of the company’s in-house sales force, and the company’s ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize any authorized or approved product; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; the timing, progress and results of the company’s discovery, preclinical and clinical development activities; clinical trial site activation, enrollment and event accumulation rates; any potential clinical trial up-sizing decision and the timing thereof; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further
analysis; the company’s ability to generate the data needed to support a potential BLA submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitopes that pemivibart and VYD2311 target remain structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies to prevent or treat COVID-19 or other infectious diseases may adversely impact the development or commercial success of the company’s product candidates; the company’s reliance on third parties; whether the anticipated benefits of the company’s partnership with Lindsey Vonn are realized; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Contacts:
Media Relations
(781) 208-0160
media@invivyd.com
Investor Relations
(781) 208-1747
investors@invivyd.com
INVIVYD, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
| December 31, 2025 |
December 31, 2024 |
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| Assets |
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| Current assets: |
||||||||
| Cash and cash equivalents |
$ | 226,689 | $ | 69,349 | ||||
| Accounts receivable, net(1) |
13,919 | 10,906 | ||||||
| Prepaid expenses and other current assets |
6,859 | 20,426 | ||||||
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| Total current assets |
247,467 | 100,681 | ||||||
| Inventory |
25,499 | 25,907 | ||||||
| Property and equipment, net |
1,365 | 1,508 | ||||||
| Operating lease right-of-use assets |
2,442 | 1,385 | ||||||
| Other non-current assets |
110 | 34 | ||||||
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| Total assets |
$ | 276,883 | $ | 129,515 | ||||
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| Liabilities and Stockholders’ Equity |
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| Current liabilities: |
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| Accounts payable |
$ | 13,744 | $ | 10,448 | ||||
| Accrued expenses (2) |
19,053 | 50,197 | ||||||
| Operating lease liabilities |
1,314 | 1,304 | ||||||
| Other current liability |
52 | 27 | ||||||
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| Total current liabilities |
34,163 | 61,976 | ||||||
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| Operating lease liabilities, non-current |
1,180 | — | ||||||
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| Total liabilities |
35,343 | 61,976 | ||||||
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| Commitments and contingencies |
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| Stockholders’ equity: |
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| Preferred stock (undesignated), $0.0001 par value; 10,000,000 shares authorized and no shares issued and outstanding at December 31, 2025 and December 31, 2024 |
— | — | ||||||
| Common stock, $0.0001 par value; 1,000,000,000 shares authorized, 281,987,033 shares issued and outstanding at December 31, 2025; 119,835,162 shares issued and outstanding at December 31, 2024 |
28 | 12 | ||||||
| Additional paid-in capital |
1,196,036 | 969,526 | ||||||
| Accumulated other comprehensive loss |
(41 | ) | (5 | ) | ||||
| Accumulated deficit |
(954,483 | ) | (901,994 | ) | ||||
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| Total stockholders’ equity |
241,540 | 67,539 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 276,883 | $ | 129,515 | ||||
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| (1) | Includes an allowance for doubtful accounts of $323 and $0 for the years ended December 31, 2025 and 2024, respectively. |
| (2) | Includes related-party amounts of $703 and $1,274 for the years ended December 31, 2025 and 2024, respectively. |
INVIVYD, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share amounts)
| Year Ended December 31, 2025 |
Year Ended December 31, 2024 |
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| Revenue: |
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| Product revenue, net |
$ | 53,426 | $ | 25,384 | ||||
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| Total revenue |
53,426 | 25,384 | ||||||
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| Operating costs and expenses: |
||||||||
| Cost of product revenue(1) |
3,747 | 1,618 | ||||||
| Research and development(2) |
38,308 | 137,254 | ||||||
| Selling, general and administrative |
66,931 | 63,388 | ||||||
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|
|
|
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| Total operating costs and expenses |
108,986 | 202,260 | ||||||
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|
|
|
|||||
| Loss from operations |
(55,560 | ) | (176,876 | ) | ||||
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| Other income: |
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| Other income, net |
3,071 | 6,951 | ||||||
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|
|
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| Total other income, net |
3,071 | 6,951 | ||||||
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|
|
|
|||||
| Net loss |
(52,489 | ) | (169,925 | ) | ||||
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|
|
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| Other comprehensive income (loss) |
||||||||
| Unrealized (loss) gain, net of tax |
(36 | ) | 8 | |||||
|
|
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|
|||||
| Comprehensive loss |
$ | (52,525 | ) | $ | (169,917 | ) | ||
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| Net loss per share attributable to common stockholders, basic and diluted |
$ | (0.30 | ) | $ | (1.43 | ) | ||
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| Weighted-average common shares outstanding, basic and diluted |
172,212,902 | 118,555,073 | ||||||
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| (1) | Includes related-party amounts of $2,137 and $1,027 for the years ended December 31, 2025 and 2024, respectively. |
| (2) | Includes related-party amounts of $4,557 and $4,546 for the years ended December 31, 2025 and 2024, respectively. |
Exhibit 99.2 Invivyd Q4 Earnings Call & Business Update March 5, 2026 © 2026 Invivyd, Inc. All trademarks used in this presentation are the property of their respective owners. 1
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Statements in this presentation that are not statements of historical fact are forward-looking statements. Words such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “seek,” “could,” “intend,” “target,” “aim,” “project,” “designed to,” “estimate,” “believe,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, though not all forward-looking statements contain these identifying words. Forward-looking statements include statements concerning, among other things, expectations regarding Invivyd’s efforts to develop potential best-in-class antibody therapies across multiple viral threats; expectations about the COVID landscape; beliefs about limitations of COVID vaccines and the expected advantages of monoclonal antibodies (mAbs); plans related to the company’s research and development activities, and the timing and potential results thereof; the potential of VYD2311 as a mAb candidate; expectations regarding the company’s clinical trial designs, enrollment, regulatory pathway, product profile, target patient population, indication and administration paradigm for VYD2311, including with respect to the company’s REVOLUTION clinical program and the timing of results related thereto; the potential of PEMGARDA® (pemivibart) as a mAb for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised persons; the company’s commercialization plans, strategies, goals and expectations; the potential of VBY329 as a novel, potential best-in-class respiratory syncytial virus (RSV) mAb candidate; expectations about the market size and opportunity for the company’s product candidates, as well as its market position; expectations regarding the company’s commercial foundation, including its commercial team, messaging and market access strategy; the potential of Invivyd’s technology to address major needs beyond COVID; the potential of the company’s pipeline and discovery efforts, including for COVID, Long COVID, Post-Vaccination Syndrome, RSV and measles; the anticipated focus and goals of the SPEAR Study Group; expectations regarding the company’s partnership with Lindsey Vonn and plans for an educational campaign to elevate public understanding of antibodies and their role in disease protection; the company’s business strategies and objectives, and ability to execute on them; the company’s future prospects; and other statements that are not historical fact. The company may not actually achieve the plans, intentions or expectations disclosed in the company’s forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the company’s actual results to differ materially from the results described in or implied by the forward-looking statements, including, without limitation: uncertainties regarding the company’s expectations, projections and estimates regarding future costs and expenses, future revenue, capital requirements, and the availability of and the need for additional financing; uncertainties regarding market acceptance, payor coverage and reimbursement, or future revenue generated by any authorized or approved product; how long the emergency use authorization (EUA) granted by the U.S. Food & Drug Administration (FDA) for PEMGARDA will remain in effect and whether such EUA is revised or revoked by the FDA; the ability to maintain a continued acceptable safety, tolerability and efficacy profile of any product candidate following regulatory authorization or approval; the success of the company’s in-house sales force, and the company’s ability to maintain and expand sales, marketing and distribution capabilities to successfully commercialize any authorized or approved product; changes in expected or existing competition; changes in the regulatory environment; the outcome of the company’s engagement with regulators; uncertainties related to the regulatory authorization or approval process, and available development and regulatory pathways; whether or not any preclinical candidate identified by the company is determined to be suitable for clinical development; the timing, progress and results of the company’s discovery, preclinical and clinical development activities; clinical trial site activation, enrollment and event accumulation rates; any potential clinical trial up-sizing decision and the timing thereof; unexpected safety or efficacy data observed during preclinical studies or clinical trials; the risk that results of nonclinical studies or clinical trials may not be predictive of future results, and interim data are subject to further analysis; the company’s ability to generate the data needed to support a potential Biologics License Application (BLA) submission for VYD2311; potential variability in neutralizing activity of product candidates tested in different assays, such as pseudovirus assays and authentic assays; variability of results in models and methods used to predict activity against SARS-CoV-2 variants; whether the epitopes that pemivibart and VYD2311 target remain structurally intact and the company’s product candidates are able to demonstrate and sustain neutralizing activity against major SARS-CoV-2 variants, particularly in the face of viral evolution; the risk that a lack of awareness of mAb therapies and regulatory scrutiny of mAb therapies to prevent or treat COVID-19 or other infectious diseases may adversely impact the development or commercial success of the company’s product candidates; the company’s reliance on third parties; whether the anticipated benefits of the company’s partnership with Lindsey Vonn are realized; complexities of manufacturing mAb therapies; macroeconomic and political uncertainties; the company’s ability to continue as a going concern; and whether the company has adequate funding to meet future operating expenses and capital expenditure requirements. Other factors that may cause the company’s actual results to differ materially from those expressed or implied in the forward-looking statements in this presentation are described under the heading “Risk Factors” in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, each filed with the Securities and Exchange Commission (SEC), and in the company’s other filings with the SEC, and in its future reports to be filed with the SEC and available at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and Invivyd undertakes no duty to update such information whether as a result of new information, future events or otherwise, except as required under applicable law. This presentation contains hyperlinks to information that is not deemed to be incorporated by reference in this presentation. All trademarks used in this presentation are the property of their respective owners. 2
01 Executive Summary 02 Clinical and Regulatory Update 03 Commercial Update agenda 04 Financial Highlights 05 Q&A 3
Michael Mina, M.D., Ph.D., appointed Chief Medical Officer Continued quarter-over-quarter growth with more HCPs prescribing Fully enrolled; Fast Track designation granted; on track for top-line data mid-year Fueling the Future FDA alignment on protocol Plan to initiate Phase 2 clinical trial in SPEAR Study Long COVID and Post-Vaccination Syndrome Group Potential best-in-class RSV antibody VBY329 candidate nominated 4
01 Executive Summary 02 Clinical and Regulatory Update 03 Commercial Update agenda 04 Financial Highlights 05 Q&A 5
Perceived as Influenza RSV a “respiratory” Entry via sialic acid receptor Entry via CX3CR1 Largely bronchoepithelial cells Largely bronchoepithelial cells virus because of transmission, but actually a vascular, prothrombotic, SARS-CoV-2 immunomodulatory Entry via ACE2 Epithelial and endothelial cells novel virus 6
The Clinical Data Phase 3 RCTs: ~2 months of efficacy follow-up Current Disconnected The FDA Labels state of COVID “Once – OR – More than 2 months since last boost dose” mRNA vaccine prevention Observed Utilization Annual booster Sources: (1) Vaccines and Related Biological Products Advisory Committee Briefing Documents, December 10, 2020. (2) Prescribing Information – COMIRNATY® Aug 2025; Prescribing Information - SPIKEVAX® Aug 2025 (3) New England 7 Journal of Medicine, An Evidence-Based Approach to Covid-19 Vaccination, Vinay Prasad, M.D., M.P.H., and Martin A. Makary, M.D., M.P.H., May 20, 2025.
Day 90 Day 1 Day 30 Day 60 End of Study 60-Day Treatment Period 30-Day Follow-up Period VYD2311 Placebo Placebo VYD2311-SD (single dose) R VYD2311 VYD2311 VYD2311 VYD2311-MD Screening 1:1:1 (multidose) (up to Day -14) N1770 Placebo Placebo Placebo Placebo Monitor for CLI symptoms: Day 1 to Day 90 If qualifying CLI symptoms: Confirm in-person with SARS-CoV-2 RT-PCR within 2 days *Day 8 and Day 68 PK for ≈ 200 participants at select sites Day 1 End of Study 30-Day Follow-up Period VYD2311-SD (single dose) R mRNA Vaccine Screening 1:1:1 (single dose) (up to Day -14) N~210 Combination VYD2311 and mRNA Vaccine Phase 3 trial to examine safety and immunology of VYD2311 combined with and versus an mRNA vaccine 8
VYD2311 COVID prevention VYD2311 COVID prevention • Phase 3, BLA-enabling trial of VYD2311 fully enrolled • Alignment reached with FDA on Phase 3 trial to examine safety and immunology of VYD2311 • Early COVID event rates on-track combined with and versus an mRNA vaccine • Potential for modest upsizing in ~April 2026 timeframe • Study design being finalized with target mid- • FDA granted Fast Track designation year start • Top-line data expected mid-year VBY329 RSV prevention/treatment Measles antibody candidate • Selected potential best-in-class RSV antibody • Update expected 1H 2026 candidate • Goal is for first- and best-in-class mAb for • Advancement toward IND-readiness 2H 2026 treatment, prophylaxis, and pediatric vaccine schedule enhancement 9
01 Executive Summary 02 Clinical and Regulatory Update 03 Commercial Update agenda 04 Financial Highlights 05 Q&A 10
More and more HCPs and patients are choosing monoclonal antibodies. It’s common sense. 11
PEMGARDA is helping establish Invivyd’s long-term commercial foundation PEMGARDA Established Strong Commercial Foundation $17.2M Net Product Revenue Q4 ’25 In-line commercial team and Continued sales growth QoQ in infrastructure to support long-term 2025 growth Building from Specialty Infusion Team – Accounts w/ PEMGARDA Infusion Experience 926 Scaling to serve broad market for VYD2311, if approved PEMGARDA field force sized Expanding commercial team to to meet the market at increase reach into broader HCP Reordering Accounts centers of excellence audiences 77% Developed Focus Messaging to build from – VYD2311 requires a greater presence Available Sites Infusing 1250+ Expanding digital presence to reach Establish scalable foundation for more HCP specialties mass consumer market Conferences/Exhibits 125+ Attended Access Strategy Shift to serve much larger opportunity GPO Contracted Sites Expand PEMGARDA market access >96% of medical claims in 2025 15,500+ position for VYD2311 potential successfully processed All metrics are Launch to Date (LTD 12/31/25) 12
13
01 Executive Summary 02 Clinical and Regulatory Update 03 Commercial Update agenda 04 Financial Highlights 05 Q&A 14
Financial highlights Q4 2025 PEMGARDA® (pemivibart) net product revenue of $17.2 million • 25% growth over Q4 2024 • 31% growth over Q3 2025 December 2025 ending cash $226.7M • Raised over $200M in the second half of 2025 PEMGARDA® Net Product Revenue Q1 Q2 Q3 Q4 2024 $0 $2.3M $9.3M $13.8M 2025 $11.3M $11.8M $13.1M $17.2M 15
01 Executive Summary 02 Clinical and Regulatory Update 03 Commercial Update agenda 04 Financial Highlights 05 Q&A 16
17
FAQ
How did Invivyd (IVVD) perform financially in full-year 2025?
What were Invivyd’s cash and balance sheet levels at December 31, 2025?
How is PEMGARDA contributing to Invivyd’s results and commercial footprint?
What progress did Invivyd report on its VYD2311 COVID-19 antibody program?
Which other pipeline programs is Invivyd (IVVD) advancing beyond VYD2311?
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Filing Exhibits & Attachments
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