secwatch.observer — SEC 8-K summary
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Issuer:     Invivyd, Inc. (IVVD)
CIK:        0001832038
Form:       8-K
Filed at:   2024-10-29T23:59:59+00:00
Accession:  0000950170-24-117934
Event type: earnings
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Invivyd reports preliminary Q3 2024 PEMGARDA revenue of $9.3M, withdraws 2024 guidance, targets 1H 2025 profitability
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- Preliminary Q3 2024 PEMGARDA net product revenue of $9.3M; cash and equivalents ~$107M as of Sept 30.
- Withdraws prior 2024 revenue guidance of $150-200M citing late-Q3 FDA Fact Sheet warning on pemivibart activity.
- Targets near-term profitability in 1H 2025 using existing cash, anticipated revenue growth, and operational efficiencies.
- Phase 3 CANOPY data: PEMGARDA provided 64% RRR vs placebo in months 7-12, total 12-month RRR 76% (nominal p<0.0001).
- Expects to end 2024 with $65M+ cash; no new safety signals in months 7-12 follow-up.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1832038/000095017024117934/0000950170-24-117934-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1832038/000095017024117934/ivvd-20241029.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-117934

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer