secwatch.observer — SEC 8-K summary
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Issuer:     KALA BIO, Inc. (KALA)
CIK:        0001479419
Form:       8-K
Filed at:   2025-09-29T23:59:59+00:00
Accession:  0001104659-25-094125
Event type: other_material
Sentiment:  negative
Materiality: 0.90
Item codes: 2.05, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

KALA BIO Phase 2b trial fails; KPI-012 development halted; workforce cut 51%
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- CHASE Phase 2b trial of KPI-012 for PCED did not meet primary endpoint of complete healing at Week 8; secondary endpoints also failed.
- Company ceases development of KPI-012 and MSC-S platform; will explore strategic options and engage with secured lender.
- Board approved workforce reduction of ~19 employees (~51%); expected to complete in Q4 2025.
- KPI-012 was well-tolerated with no treatment-related serious adverse events observed.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1479419/000110465925094125/0001104659-25-094125-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1479419/000110465925094125/tm2527340d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-094125

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