Invivyd (NASDAQ:IVVD) executives used the company’s fourth-quarter 2025 earnings call to outline progress in its COVID-19 monoclonal antibody pipeline, provide an update on commercialization of PEMGARDA, and review recent financial results and liquidity.
Leadership update and strategic focus
Chairman Marc Elia opened the call by noting that Invivyd has brought physician-scientist Michael Mina into the company as chief medical officer. Elia said Mina was not able to join the call but would participate in future updates.
VYD2311 and the REVOLUTION program: DECLARATION enrollment complete
Elia emphasized Invivyd’s view that monoclonal antibody prophylaxis can provide “vaccine-free protection” against symptomatic COVID-19 and positioned VYD2311 as designed to be an alternative to COVID vaccination. He described VYD2311 as more potent than pemivibart in vitro and said it has a longer measured half-life, which the company believes could enable protection comparable to PEMGARDA in a more scalable intramuscular form.
Invivyd’s pivotal focus is the DECLARATION study, described on the call as a “triple-blind randomized clinical trial” evaluating VYD2311 safety and its ability to reduce symptomatic PCR-positive COVID-19 versus placebo. Elia said the target enrollment is approximately 1,770 subjects randomized 1:1:1 across two active arms and one placebo arm, and that the trial has reached its target enrollment and may “modestly over-enroll” as sites complete screening already in progress.
Elia also reported that the study’s Independent Data Monitoring Committee conducted a pre-specified review of unblinded safety and tolerability data from early participant experience and issued written recommendations that included:
- Allowing pregnant and breastfeeding women to enroll
- Removing the requirement that women of childbearing age use contraception while enrolled
- Eliminating certain pre-specified safety visits at days 8, 38, and 68 post-dose
On timing, Elia reiterated the company’s “mid-year” guidance for DECLARATION results, which he defined as 2Q or 3Q 2026, while noting that statistical power depends on the study’s “attack rate” and event accumulation. He said COVID events had begun to appear in the trial and that event accumulation is “on track to date” based on current projections.
Elia explained that DECLARATION includes a pre-specified upsizing algorithm that could add participants if event rates suggest more power is needed, with a potential analysis around April. He said the company would update investors on next steps at that time and added that an upsizing, if triggered, may not meaningfully delay the company’s mid-year guidance.
In the Q&A, Elia provided additional color on the resizing framework, describing it as a pre-specified mechanism intended to add power if efficacy were lower than modeled. He suggested an upsizing might be “approximately another 30% of the study or so” and said Invivyd would prefer to add power if needed, even if it brings “a relatively modest timing and overall financial penalty.”
LIBERTY and myocarditis monitoring
During the Q&A, Elia also addressed myocarditis monitoring in the LIBERTY study, which he described as a comparative and combination study involving mRNA-based COVID vaccination. He said myocarditis/pericarditis is not something Invivyd sees with antibodies and that, at least initially, myocarditis monitoring in LIBERTY would be a “yes/no” assessment, noting the study is small and not powered to detect very low-frequency events.
PEMGARDA commercialization: growth, reorders, and footprint expansion
Chief Commercial Officer Tim Lee said Invivyd continues to see clinicians increasingly turn to monoclonal antibodies for prevention in appropriate high-risk patients, citing inclusion in guidelines from organizations such as the Infectious Diseases Society of America and the National Comprehensive Cancer Network. Lee highlighted PEMGARDA’s inclusion in NCCN guidelines for B-cell lymphomas as an example of broader recognition.
Lee said the company is seeing growing interest across multiple specialties, including hematology, oncology, rheumatology, infectious disease, transplant, and neurology. He characterized Invivyd’s work as “building a category” and reported several commercial metrics, including:
- A 77% reorder rate among accounts
- More than 15,000 contracted GPO sites, which he said significantly expands the commercial footprint
Lee also discussed Invivyd’s partnership with Lindsey Vonn, describing the collaboration as part of the company’s efforts to educate on proactive immune protection and the role antibodies can play in helping individuals “stay well.”
Pipeline notes: long COVID, RSV, and measles
Elia said Invivyd is excited to begin clinical exploration of antibodies in long COVID and post-vaccination syndrome, referencing prior disclosure earlier in the quarter. He also noted that ACIP had announced it would hold a “full discussion” on both topics at a meeting scheduled for March 18-19, which the company said it would watch with interest. Elia added that Invivyd’s collaboration with the SPEAR Study Group has yielded a clinical trial design the company is moving forward “with all haste.”
On RSV, Elia said Invivyd identified a “highly potent, potentially best-in-class RSV antibody” in the fourth quarter and believes its properties are competitive with current standard of care in certain neonatal and pediatric populations. In the Q&A, Chief Scientific Officer Dr. Robbie Allen said Invivyd applied lessons from COVID antibody development, including designing with evolutionary drift in mind. Allen said RSV has shown “a considerable amount of drift” since the screening that supported currently marketed antibodies, and he described Invivyd’s program as intended to address drift and “known liabilities” of existing actives.
On measles, Elia reiterated prior guidance that Invivyd expects to update investors in the first half of the year. In response to an analyst question, he discussed potential use cases in conceptual terms, including treatment, post-exposure prophylaxis, outbreak response (including “ring immunization” concepts), and the idea of using antibodies as a “vaccine enhancement” approach for very young children. Allen added that the measles program was driven by inbound requests from healthcare providers for a solution in treatment or post-exposure prophylaxis settings.
Financial results: revenue growth and cash position
Chief Financial Officer Bill Duke said PEMGARDA net revenues grew 31% over third quarter 2025 and 25% over fourth quarter 2024. Duke reported 2025 full-year net revenues of $53.4 million, which he attributed to continued efforts to drive market awareness.
Duke also said Invivyd raised over $200 million in the second half of 2025 and ended the year with $226.7 million in cash and cash equivalents. He said this leaves the company well-capitalized through anticipated pivotal data for VYD2311 in mid-2026 and, depending on PEMGARDA growth and “continued operational discipline,” potentially beyond that period.
About Invivyd (NASDAQ:IVVD)
Invivyd, Inc, a commercial-stage biopharmaceutical company, focuses on the discovery, development, and commercialization of antibody-based solutions for infectious diseases in the United States. The company developed INVYMAB, a platform that combines viral surveillance and predictive modeling with advanced antibody engineering. Its pipeline includes PEMGRADA (pemivibart) injection, a half-life extended investigational monoclonal antibody (mAb) for the prevention of COVID-19 in adults and adolescents; VYD2311, an mAb candidate which is in preclinical studies for the prevention or treatment for COVID-19; and adintrvimab, that is in phase 3 clinical trials for the prevention or treatment of COVID-19.
