other material
confidence high
sentiment positive
materiality 0.90
Achieve Life Sciences reports positive Phase 3 ORCA-2 results; cytisinicline shows 6-8x odds of smoking abstinence
ACHIEVE LIFE SCIENCES, INC.
- Primary endpoints met: 12-week cytisinicline had 32.6% abstinence vs 7.0% placebo (OR 6.3, p<0.0001); 6-week had 25.3% vs 4.4% (OR 8.0, p<0.0001).
- Secondary continuous abstinence weeks 9-24: 21.1% for 12-week arm vs 4.8% placebo (OR 5.3, p<0.0001); weeks 3-24: 8.9% vs 2.6% (OR 3.7, p=0.0016).
- Well tolerated; no treatment-related serious adverse events. Most common AEs (>5%): insomnia, abnormal dreams, headache, nausea.
- SVB approved remaining $10M of $25M debt facility; terms: interest at greater of 3.5% or WSJ prime, interest-only through Apr 2024, then 24-month amortization.
- Facility available through Apr 30, 2023; no amounts drawn at close; discretionary draws allowed.