secwatch.observer — SEC 8-K summary
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Issuer:     Replimune Group, Inc. (REPL)
CIK:        0001737953
Form:       8-K
Filed at:   2025-05-22T23:59:59+00:00
Accession:  0001104659-25-051847
Event type: earnings
Sentiment:  positive
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Replimune Q4 net loss $74.1M; RP1 BLA on track for July 22 PDUFA
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- Net loss Q4 $74.1M, FY $247.3M; cash $483.8M, runway into Q4 2026 excluding revenue.
- BLA for RP1+nivolumab in advanced melanoma on schedule; PDUFA July 22, 2025; no advisory committee.
- Commercial infrastructure fully built and ready for launch; distribution channels established.
- R&D Q4 $54.0M (+27% YoY); SG&A Q4 $25.4M (+57% YoY) driven by pre-launch scaling.
- Investor day June 24; confirmatory Phase 3 IGNYTE-3 enrolling 400 patients globally.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1737953/000110465925051847/0001104659-25-051847-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1737953/000110465925051847/tm2515645d2_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-051847

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