secwatch.observer — SEC 8-K summary
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Issuer:     Replimune Group, Inc. (REPL)
CIK:        0001737953
Form:       8-K
Filed at:   2025-08-07T23:59:59+00:00
Accession:  0001104659-25-074989
Event type: earnings
Sentiment:  negative
Materiality: 0.80
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Replimune reports Q1 FY2026 net loss $86.7M; FDA issues CRL for RP1 BLA
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- Net loss of $86.7M for quarter ended June 30, 2025, vs $53.8M a year ago.
- Cash, cash equivalents and short-term investments $403.3M; funding expected into Q4 2026.
- FDA issued Complete Response Letter for RP1 BLA in advanced melanoma on July 22, 2025.
- R&D expenses $57.8M (up from $43.0M); SG&A $32.6M (up from $14.4M), driven by commercial prep.
- Ongoing Phase 3 IGNYTE-3 trial for RP1+nivolumab; Phase 2/3 REVEAL trial for RP2 in uveal melanoma.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1737953/000110465925074989/0001104659-25-074989-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1737953/000110465925074989/tm2522849d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-074989

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