Invivyd Q1 Earnings Call Highlights
Invivyd (NASDAQ:IVVD) said its first quarter of 2026 was marked by continued progress in its pivotal COVID-19 antibody program, year-over-year growth for PEMGARDA and elevated clinical spending tied to its VYD2311 development efforts.
On the company’s earnings call, Chairman Marc Elia said Invivyd’s pivotal DECLARATION study for VYD2311 remains on schedule after the company triggered an upsizing of the study in early April. Elia said recruitment into the expanded cohort moved “well faster” than internal expectations, prompting Invivyd to slow enrollment temporarily during a lull in COVID-19 and broader respiratory disease activity in order to extend patient exposure into what the company expects could be a normal summer COVID wave.
“We’ve resumed full speed recruitment and believe we will finish up imminently, keeping the program on time with our previous estimates,” Elia said.
VYD2311 Study Advances With Shorter Monitoring Period
Chief Medical Officer Dr. Michael Mina said the Independent Data Monitoring Committee recently recommended reducing post-dose monitoring in the DECLARATION study from two hours to 30 minutes after reviewing unblinded VYD2311 safety data. Mina said the study has been modified accordingly, and the company views the change as a potentially encouraging sign for safety and tolerability after administration.
During the question-and-answer session, analysts asked whether the 30-minute monitoring period could ultimately appear in VYD2311’s label if approved. Elia said it was too early to know and emphasized that the change reflects the evolution of the clinical program rather than a final commercial or regulatory position. Mina added that Invivyd anticipates an intramuscular monoclonal antibody could eventually resemble common post-vaccination waiting practices as physicians become more comfortable with the product profile.
Mina also said Invivyd aims to open and begin recruiting the LIBERTY study shortly. That study is intended to evaluate the safety and immunology of combining a COVID-19 vaccine with a monoclonal antibody and to prospectively compare the safety and tolerability of monoclonal antibody approaches against mRNA vaccination.
Company Highlights Reactogenicity Thesis
A central theme of the call was Invivyd’s view that monoclonal antibodies may offer an advantage over vaccines in terms of systemic reactogenicity, or short-term symptoms such as fever, chills, headache and fatigue after immunization. Mina discussed a recent manuscript analyzing adintrevimab, an earlier investigational Invivyd antibody that completed a placebo-controlled pivotal prevention study.
Mina said the company compared symptom categories from the adintrevimab EVADE study with symptoms reported in Sanofi’s COMPARE Phase IV study of protein-based and mRNA-based COVID-19 vaccines. He cautioned that there were “real methodological differences” between the studies and said the LIBERTY study will be needed for a direct comparison.
Even so, Mina said the results support Invivyd’s view that monoclonal antibodies do not rely on immune education in the same way as vaccines and therefore may avoid much of the inflammatory response tied to vaccination. He argued that post-immunization symptoms can affect willingness to receive future immunizations and therefore may have public health implications.
Elia said the company is not positioning the analysis as an anti-vaccine argument, but rather as part of a broader discussion about risk, benefit and tolerability. In response to an analyst question, Elia said Invivyd selected the VYD2311 dose with the expectation that corresponding antiviral titers would “conceptually generate” a 70% to 90% protective benefit against symptomatic disease, while stressing that the clinical trial will determine the actual outcome.
PEMGARDA Revenue Grows Year Over Year
Chief Commercial Officer Tim Lee said PEMGARDA grew 22% compared with the first quarter of 2025. He noted that the first quarter is typically weaker for pharmaceuticals, infectious disease and preventive medicine, but said PEMGARDA has not shown the same degree of seasonal decline expected for a seasonal respiratory vaccine.
Lee attributed that relative stability to the continuing presence of SARS-CoV-2, including periodic waves and the potential for a summer surge. He said vulnerable populations and care teams appear to be making decisions that reflect COVID-19 as an ongoing threat.
Lee said Invivyd is preparing for a potential transition to VYD2311, if approved, which he described as an “entirely new kind of COVID antibody.” While the distribution model would differ from PEMGARDA, Lee said much of the commercial infrastructure built for PEMGARDA could be leveraged and expanded for VYD2311.
The company also said it is increasing use of new channels for healthcare provider education, including leading artificial intelligence platforms, and expanding direct-to-consumer efforts to build disease and brand awareness. Lee said those consumer efforts remain in the early stages but could be scaled if VYD2311 is approved.
Pipeline Expands Beyond COVID-19
Chief Scientific Officer Dr. Robert Allen said Invivyd continues to see “attractive neutralization data” for its medicines against relevant SARS-CoV-2 variants, including formal confirmation of neutralization against Omicron BA.3.2. Allen said the company has no current expectation of future activity concerns based on the variant landscape it sees today.
Beyond COVID-19, Allen said Invivyd has disclosed early programs targeting measles and RSV, and is expanding discovery work across other vaccine-preventable viruses including mumps and rubella, as well as Borrelia burgdorferi, the bacterium associated with Lyme disease. Allen said the company views monoclonal antibody technology as underutilized in infectious disease prevention and treatment.
Clinical Spending Weighs on Burn, Cash Position Described as Strong
Invivyd said first-quarter results included meaningful clinical spending to support the DECLARATION trial, describing the investment as substantial compared with ordinary clinical and SG spending. The company said it also made targeted investments to prepare for potential VYD2311 commercialization, if approved, while noting some of those investments could also support PEMGARDA.
The company characterized its cash position as “very strong,” citing additional cash raised in April through its at-the-market offering facility from long-term investors. Invivyd said it expects continued PEMGARDA growth and a return to more normalized research and development spending as the pivotal VYD2311 trial winds down over coming quarters.
Elia closed the call by saying the company believes several important milestones are approaching “within months,” while emphasizing that regulatory outcomes and clinical data remain ahead.
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.
This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected].
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