Invivyd (IVVD) Q3 2025 earnings summary

Executive summary

• Q3 2025 net product revenue reached $13.1 million, up 41% year-over-year and 11% sequentially, driven by PEMGARDA sales after its EUA in March 2024.

• FDA cleared IND for VYD2311, with pivotal DECLARATION and LIBERTY clinical trials set to begin around year-end 2025; top-line data expected mid-2026.

• Raised over $87 million in capital through public offering and ATM facility, with cash exceeding $100 million by October 2025, ensuring strong financial positioning for clinical and commercial expansion.

• Net loss for Q3 2025 was $10.5 million, a significant improvement from $60.7 million in Q3 2024, reflecting lower R&D expenses.

• Developing antibody therapies targeting COVID, Long COVID, RSV, and measles, with a focus on rapid execution and broad market impact.

Financial highlights

• Q3 2025 PEMGARDA net product revenue was $13.1 million, compared to $9.3 million in Q3 2024 and $11.8 million in Q2 2025.

• Cash and cash equivalents were $85.0 million at quarter-end, increasing to over $100 million by October 2025 after a $57.5 million public offering and $29.8 million from ATM facility.

• R&D expenses dropped to $8.0 million from $57.9 million year-over-year, mainly due to lower manufacturing and clinical trial costs.

• Net loss for Q3 2025 was $10.5 million, a significant improvement from $60.7 million in Q3 2024.

• Gross margin for Q3 2025 was approximately 91.7%.

Outlook and guidance

• Pivotal DECLARATION and LIBERTY studies for VYD2311 are on track to initiate around year-end 2025, with top-line data expected mid-2026.

• Commercial build-out and go-to-market strategy for VYD2311 underway, with scalable manufacturing and supply planned.

• Pipeline expansion efforts initiated, targeting RSV and measles beyond SARS-CoV-2.

• Updates on RSV and measles antibody discovery programs expected before year-end, with potential for rapid clinical advancement.

• Substantial doubt exists about the ability to continue as a going concern beyond one year without additional funding.