secwatch.observer — SEC 8-K summary
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Issuer:     IOVANCE BIOTHERAPEUTICS, INC. (IOVA)
CIK:        0001425205
Form:       8-K
Filed at:   2022-11-03T23:59:59+00:00
Accession:  0001104659-22-114414
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Iovance Q3 net loss $99.6M ($0.63/sh); BLA submission for lifileucel on track to complete in Q4 2022
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- Cash, equivalents, investments & restricted cash $366.6M at Sep 30, 2022, down from $602.1M at Dec 31, 2021; runway into 2024.
- Net loss $99.6M vs $86.1M YoY; R&D expense $72.5M (+$7.1M), G&A $27.9M (+$7.0M).
- Rolling BLA for lifileucel in advanced melanoma started August 2022, expected to complete in Q4 2022.
- Phase 3 trial of lifileucel + pembrolizumab in frontline advanced melanoma on track to begin late 2022.
- iCTC facility annual capacity for 2,000+ patients; new cGMP manufacturing suites for commercial supply.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1425205/000110465922114414/0001104659-22-114414-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1425205/000110465922114414/tm2229606d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-22-114414

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