secwatch.observer — SEC 8-K summary
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Issuer:     REGENXBIO Inc. (RGNX)
CIK:        0001590877
Form:       8-K
Filed at:   2022-05-04T23:59:59+00:00
Accession:  0001564590-22-017853
Event type: earnings
Sentiment:  negative
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

REGENXBIO Q1 net loss widens to $76.7M; delays RGX-202 Duchenne trial initiation to H1 2023
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- Net loss of $76.7M ($1.79/sh) vs $50.1M loss ($1.20/sh) in Q1 2021; revenue $22.2M up 17% YoY on Zolgensma royalties.
- Cash $764.8M, operational runway into 2025; net loss includes $9.2M non-recurring charge from UPenn license amendment.
- RGX-314 pivotal trials for wet AMD on track; BLA submission expected in 2024.
- RGX-202 Duchenne trial dosing delayed to H1 2023 due to manufacturing observation; trial prep continues.
- cGMP manufacturing facility operational for up to 2000L scale; '5x'25' strategy to advance five AAV therapeutics by 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1590877/000156459022017853/0001564590-22-017853-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1590877/000156459022017853/rgnx-8k_20220504.htm
  HTML page:      https://secwatch.observer/filing/0001564590-22-017853

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