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8-K2026-05-14· deepseek-chat

IVVD · Invivyd, Inc.

0001193125-26-222762

SEC filing

Summary

Invivyd reported Q1 2026 PEMGARDA net product revenue of $13.7M, a 22% increase year-over-year, and provided updates on its VYD2311 clinical program.

Key takeaways

Full analysis

Invivyd reported first quarter 2026 financial results, highlighting a 22% year-over-year increase in PEMGARDA net product revenue to $13.7 million, driven by continued commercial execution despite waning vaccine uptake. Research and development expenses surged to $30.7 million from $10.6 million in the prior year, primarily due to costs associated with the DECLARATION pivotal trial for VYD2311. Selling, general and administrative expenses rose to $25.1 million from $16.8 million, reflecting increased personnel and commercial marketing costs. The net loss widened to $41.4 million ($0.13 per share) from $16.3 million ($0.14 per share) in Q1 2025, as higher operating expenses outpaced revenue growth. The company ended the quarter with $184.2 million in cash and equivalents, and raised an additional ~$20 million in April 2026 through its ATM facility, providing runway through the DECLARATION data readout and potential VYD2311 launch. Management emphasized diligent expense management outside of non-recurring clinical expenditures and expressed confidence in the balance sheet strength. Key clinical updates include the DECLARATION trial upsizing by ~500 subjects, with top-line data now expected in Q3 2026, and an IDMC recommendation to reduce post-dose monitoring time for VYD2311 from two hours to 30 minutes. In vitro data confirmed neutralizing activity of both pemivibart and VYD2311 against the emerging BA.3.2.2 variant. The company also advanced its pipeline with a measles mAb candidate VMS063 and plans for VBY329 in pediatric RSV prophylaxis. The LIBERTY head-to-head trial comparing VYD2311 to mRNA vaccines is on track to initiate in Q2 2026. Overall, the earnings release underscores Invivyd's progress in commercializing PEMGARDA while advancing its lead candidate VYD2311 toward a pivotal data readout and potential launch.