📄 What This Document Is

This is an 8-K filing with an attached press release (Exhibit 99.1). Companies use 8-Ks to announce major news to investors. Today's news from Invivyd is all about big progress and a brand-new weapon in their fight against viruses.

👉 In simple terms: Invivyd is reporting strong data from its late-stage COVID-19 antibody trial and is launching a new project to create a groundbreaking treatment for measles.

🏢 What The Company Does

In simple terms... Invivyd is a biotech company that engineers powerful, lab-made antibodies. Think of them as precision-guided medicines that can immediately block a virus, unlike vaccines which take time to train your immune system. They are focused on serious respiratory viruses, starting with COVID-19 and now expanding to measles.

Their goal is to build a platform that can quickly create new antibodies for different viruses, making them a multi-virus powerhouse.

🚀 Key Moves & Clinical Progress

1. COVID-19 Program (VYD2311) is Accelerating

Invivyd's main COVID project is VYD2311, a next-generation antibody to prevent COVID-19. Its pivotal Phase 3 DECLARATION study just hit a major milestone.

What Happened: The study uses a clever "re-estimation" rule. When 1,500 patients reached the halfway point (April 6th), they had already seen enough COVID cases to confirm strong statistical power. This triggered a pre-planned study upsizing.
The Upsize: They are adding ~500 more participants to make the results even more robust. The total study size grows from 1,818 to about 2,300 people.
Timeline Shift: Because of the larger study, top-line results will now likely come in Q3 2026, a modest delay from the previous "mid-year" (Q2/Q3) guidance.
Regulatory Win: Invivyd and the FDA agreed on a plan (an "Initial Pediatric Study Plan") for a future study in kids aged 0-11. This is called the "DRUMMER" study and will only happen if the main DECLARATION trial succeeds.

👉 Why it matters: This isn't a setback. The upsizing shows the trial is working as designed and increases confidence in getting a clear, powerful result. The FDA alignment smooths the path for a future approval in children.

2. A New Star: The Measles Antibody (VMS063)

This is the big new announcement. Invivyd used its tech to invent VMS063, a potential first-in-class antibody for measles.

The Problem: Measles is making a scary comeback in 2026 due to lower vaccination rates. There is no approved treatment, only supportive care. Vaccines are crucial but don't work for everyone (like infants or the immunocompromised).
The Solution (VMS063): This antibody is designed to:
- Treat active measles to shorten illness and prevent severe complications.
- Prevent infection after exposure (post-exposure prophylaxis).
- Protect vulnerable groups like infants before they can get vaccinated.
Its Strengths: Early lab tests show it's extremely potent against all recent measles strains and is designed to last a long time in the body from a single dose.

👉 Why it matters: This targets a massive unmet medical need during a real public health crisis. It represents Invivyd's strategy to use its antibody "platform" to rapidly create new drugs for other dangerous viruses.

🔮 What's Next

Invivyd has a clear, packed roadmap:

Finish enrolling the bigger DECLARATION COVID trial and await results in Q3 2026.
Advance VMS063 through "IND-enabling" studies (the lab and animal work needed before human trials) with a goal of being ready for a first-in-human study by late 2026.
Plan the pediatric "DRUMMER" study for VYD2311, pending a successful main trial.
Hinted at more to come: They plan to announce discoveries for additional pathogens later in 2026.

⚖️ The Big Picture

👍 Strengths & Opportunities

Powerful Platform: Their tech can rapidly generate best-in-class antibodies, as proven with both COVID and now measles.
Near-Term Catalyst: The DECLARATION study result in Q3 2026 is a major event that could lead to a new COVID prevention option.
Huge Unmet Need: Measles is a resurging threat with no specific treatment. VMS063 could be a game-changer for vulnerable populations.
Regulatory Strategy: Aligning with the FDA on the pediatric plan early is savvy and de-risks the program.

⚠️ Risks & Challenges

Clinical Trial Risk: The DECLARATION study must succeed. If it fails, the whole COVID program stalls.
Regulatory Hurdles: Even with good data, the FDA must approve any product. The path for a new measles antibody is uncharted.
Competitive & Market Landscape: It's unclear how a new COVID antibody would be used or reimbursed if updated vaccines remain available.
Funding: Advanced clinical trials are extremely expensive. The company will need capital to execute its ambitious plans.

🧠 The Analogy

Invivyd is like a master locksmith for viruses. For COVID-19, they've already crafted a high-tech key (VYD2311) and are in the final stages of proving it works on the current lock (the virus). Now, using the same locksmithing tools, they've just announced they've designed a brilliant new key for a different, very dangerous lock (measles) that nobody has been able to pick before. Their platform lets them do this rapidly and effectively.

🧩 Final Takeaway

Invivyd is firing on two major cylinders: 1) Nearing the finish line on a pivotal late-stage study for a next-gen COVID antibody, with results expected this summer, and 2) Pivoting its powerful technology to attack a worsening measles outbreak with a potentially groundbreaking new treatment. The company is executing a clear strategy to become a multi-virus specialist.

Contacts: Media: (781) 208-0160, [email protected] | Investors: (781) 208-1747, [email protected]

Invivyd, Inc. — 8-K Filing