secwatch.observer — SEC 8-K summary
======================================

Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2022-11-03T23:59:59+00:00
Accession:  0000950170-22-021548
Event type: earnings
Sentiment:  neutral
Materiality: 0.65
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO Q3 net loss $75.5M; cash $617M; RGX-314 BLA on track for 2024
-----------------------------------------------------------------------

- Net loss of $75.5M ($1.75/share) vs $58.4M ($1.37/share) in Q3 2021; revenue $26.5M, down from $30.8M.
- Cash, equivalents & marketable securities $617M as of Sept 30, 2022, down from $849.3M at Dec 31, 2021; runway into 2025.
- RGX-314 subretinal pivotal trials (ATMOSPHERE, ASCENT) enrolling; BLA filing planned in 2024. AAVIATE and ALTITUDE trials expanded with new cohorts.
- RGX-202 AFFINITY DUCHENNE Phase I/II trial on track for first patient dosing in H1 2023; RGX-121 CAMPSIITE pivotal trial enrolling for MPS II.
- Zolgensma royalty revenue $25.2M in Q3 2022 vs $30.3M in Q3 2021; Novartis reported Q3 global sales of $319M.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000095017022021548/0000950170-22-021548-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000095017022021548/rgnx-20221103.htm
  HTML page:      https://secwatch.observer/filing/0000950170-22-021548

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