secwatch.observer — SEC 8-K summary
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Issuer:     Regulus Therapeutics Inc. (—)
CIK:        0001505512
Form:       8-K
Filed at:   2024-03-14T23:59:59+00:00
Accession:  0001193125-24-068000
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 1.01, 2.02, 3.02, 5.03, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Regulus closes $100M private placement and reports positive Phase 1b data for RGLS8429 in ADPKD
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- Oversubscribed private placement of $100M gross proceeds: 45.1M shares at $1.60 and 173,915 non-voting convertible preferred shares at $160 each.
- Phase 1b MAD cohort 2 (2mg/kg) showed mechanistic dose response (increased PC1/PC2) with no safety concerns; 3 patients with highest PC1/PC2 had >4% htTKV reduction.
- FDA Type D meeting confirmed potential accelerated approval pathway based on a single Phase 2 study of RGLS8429.
- As of Dec 31, 2023, cash was $23.8M; proceeds add ~$100M to fund development.
- Cohort 3 fully enrolled (3mg/kg), data expected mid-2024; cohort 4 (fixed 300mg) screening starts Q2 with sample size up to 30 patients.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1505512/000119312524068000/0001193125-24-068000-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1505512/000119312524068000/d767023d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-068000

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