A biopharmaceutical company making monoclonal antibody medicines for viral diseases, Invivyd's only commercial product is PEMGARDA (pemivibart), a preventive antibody given to certain immunocompromised adults and teens at risk of COVID-19. It was founded in 2020 as Adagio Therapeutics, a spin-out of the antibody-discovery firm Adimab, and renamed Invivyd in 2022. The name hints at its mission of building antibodies that outpace fast-mutating viruses.
PEMGARDA revenue rose 21% to $14.3M, but the net loss widened to $44.4M as VYD2311 trial costs drove R&D up 189%.
The company's sole product faces a hard expiration date. rose 21% to $14.3 million, but the net loss widened to $44.4 million as research and development costs nearly tripled to $30.0 million for the VYD2311 pivotal trial. The EUA that authorizes all of Invivyd's revenue will terminate on June 29, 2027, and the company has not yet received FDA on a full approval pathway.
Key takeaways
Net product from PEMGARDA rose 21% to $14.3 million, driven by increased product demand, and rose 4% sequentially from $13.7 million in Q1 2026.
Research and development expenses rose 189% to $30.0 million, primarily from a $21.5 million increase in contract research costs for the VYD2311 Phase 3 DECLARATION trial, which completed enrollment during the quarter.
The net loss widened to $44.4 million from $14.7 million in the same quarter a year ago, as the R&D ramp more than offset the contribution from product sales.
Section summaries
Management's Discussion and Analysis
Net loss widened to $85.8M in H1 2026 as surging VYD2311 clinical costs drove a $39.9M R&D increase, while PEMGARDA revenue rose 21%.
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PEMGARDA net product grew 21% to $28.0M in H1 2026, driven by increased product demand, though the is set to terminate on June 29, 2027.
Cash and cash equivalents fell to $160.1 million from $184.2 million at the end of Q1 2026, and management again stated substantial doubt about the company's ability to continue as a without additional financing.
The HHS declaration enabling COVID-19 EUAs ends June 29, 2027, which will terminate PEMGARDA's authorization and halt all product unless a BLA is approved beforehand; the company has not yet received FDA on a regulatory approval pathway for PEMGARDA.
The company received a Nasdaq delisting notice on July 23, 2026, because its stock price fell below $1.00, and must regain compliance by January 19, 2027.
What changed
The DECLARATION Phase 3 trial for VYD2311 completed enrollment, and top-line data remains on track for Q3 2026, consistent with the timeline set after the Q1 2026 upsizing.
PEMGARDA of $14.3 million in Q2 2026 partially recovered from the Q1 2026 sequential decline to $13.7 million, but remains below the Q4 2025 peak of $17.2 million.
The going-concern warning persists, and the $30 million Silicon Valley Bank term loan facility remains undrawn because the company has not met the required net product milestone, a condition flagged in every filing since the loan was secured in Q2 2025.
A new risk has materialized: the HHS declaration enabling COVID-19 EUAs will terminate on June 29, 2027, which will end PEMGARDA's authorization and halt all product unless a BLA is approved beforehand, a deadline not previously disclosed with this specificity.
What to watch
Top-line data from the DECLARATION Phase 3 trial of VYD2311, expected in Q3 2026, to assess whether the next-generation antibody can support a BLA filing before the June 2027 EUA termination.
Whether the company receives FDA on a regulatory approval pathway for PEMGARDA, without which the product's authorization ends on June 29, 2027, eliminating all .
Whether the company regains compliance with Nasdaq's $1.00 minimum bid price requirement by the January 19, 2027 deadline, or faces delisting.
Any financing activity or updated cash runway , given the unchanged going-concern warning and $160.1 million in cash.
Total R&D expenses nearly tripled to $60.1M, primarily due to a $40.6M increase in VYD2311 costs for the Phase 3 DECLARATION and LIBERTY clinical trials.
SG&A expenses surged 64% to $54.6M, driven by higher headcount costs and a $12.6M increase in professional fees, including sales and marketing.
Cash and equivalents stood at $160.1M as of June 30, 2026, but management expressed substantial doubt about the company's ability to continue as a without additional financing.
The company completed enrollment in the pivotal DECLARATION trial for VYD2311 and expects top-line data later in Q3 2026, with a potential submission to follow.
Quantitative and Qualitative Disclosures About Market Risk
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
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We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.
From time to time, we may become involved in legal proceedings or other litigation relating to claims arising in the ordinary course of business. We accrue liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reas…
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From time to time, we may become involved in legal proceedings or other litigation relating to claims arising in the ordinary course of business. We accrue liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and estimated exposure amount. Legal fees and other costs associated with such proceedings are expensed as incurred. As of June 30, 2026, we were not a party to any material legal proceedings.
PEMGARDA's EUA will terminate June 29, 2027, threatening the company's sole revenue source absent a timely BLA approval.
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The HHS declaration enabling COVID-19 EUAs ends June 29, 2027, which will terminate PEMGARDA's and halt all product unless a is approved beforehand.
The company has not yet received FDA on a regulatory approval pathway for PEMGARDA, making the timing and requirements for a uncertain.
The transition period may reduce PEMGARDA demand, disrupt payor coverage, trigger write-downs, and impair the company's ability to meet loan covenants or raise capital.
The FDA will not accept new COVID-19 requests, forcing VYD2311 and other candidates onto traditional, lengthier approval paths.
The company received a Nasdaq delisting notice on July 23, 2026 for a sub-$1.00 bid price and must regain compliance by January 19, 2027 to avoid adverse effects on liquidity and financing.