- 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 inDecember 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
“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
“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
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 theU.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 withFast 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.
- In
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 championLindsey 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.
- As announced earlier today, distinguished scientist and physician
- 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 ofDecember 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.
- 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
- Research & Development (R&D) Expenses: R&D expenses were
$38.3 million for the year endedDecember 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 endedDecember 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 endedDecember 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 endedDecember 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.
- Total shares of common stock outstanding as of
- Revenue: Reported full year 2025 net product revenue of PEMGARDA of
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,
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
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
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
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.
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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
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
CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share amounts) | ||||||||
2025 | 2024 | |||||||
| Assets | ||||||||
| 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 | ||||||
| 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 | ||||||
| Total assets | $ | 276,883 | $ | 129,515 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| 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 | ||||||
| Total current liabilities | 34,163 | 61,976 | ||||||
| Operating lease liabilities, non-current | 1,180 | — | ||||||
| Total liabilities | 35,343 | 61,976 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ equity: | ||||||||
| Preferred stock (undesignated), authorized and no shares issued and outstanding at and | — | — | ||||||
| Common stock, 281,987,033 shares issued and outstanding at 119,835,162 shares issued and outstanding at | 28 | 12 | ||||||
| Additional paid-in capital | 1,196,036 | 969,526 | ||||||
| Accumulated other comprehensive loss | (41 | ) | (5 | ) | ||||
| Accumulated deficit | (954,483 | ) | (901,994 | ) | ||||
| Total stockholders’ equity | 241,540 | 67,539 | ||||||
| Total liabilities and stockholders’ equity | $ | 276,883 | $ | 129,515 | ||||
(1) Includes an allowance for doubtful accounts of
(2) Includes related-party amounts of
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (In thousands, except share and per share amounts) | ||||||||
| Year Ended | Year Ended | |||||||
| 2025 | 2024 | |||||||
| Revenue: | ||||||||
| Product revenue, net | $ | 53,426 | $ | 25,384 | ||||
| Total revenue | 53,426 | 25,384 | ||||||
| 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 | ||||||
| Total operating costs and expenses | 108,986 | 202,260 | ||||||
| Loss from operations | (55,560 | ) | (176,876 | ) | ||||
| Other income: | ||||||||
| Other income, net | 3,071 | 6,951 | ||||||
| Total other income, net | 3,071 | 6,951 | ||||||
| Net loss | (52,489 | ) | (169,925 | ) | ||||
| Other comprehensive income (loss) | ||||||||
| Unrealized (loss) gain, net of tax | (36 | ) | 8 | |||||
| Comprehensive loss | $ | (52,525 | ) | $ | (169,917 | ) | ||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.30 | ) | $ | (1.43 | ) | ||
| Weighted-average common shares outstanding, basic and diluted | 172,212,902 | 118,555,073 | ||||||
(1) Includes related-party amounts of
(2) Includes related-party amounts of
