---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-21-017696"
form_type: "8-K"
ticker: "PTIX"
cik: "0001022899"
company_name: "Protagenic Therapeutics, Inc.new"
filed_at: "2021-07-26T23:59:59+00:00"
generated_at: "2026-06-30T02:26:36.898966+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# Protagenic Therapeutics delays PT00114 clinical trial start to Q4 2021 after FDA request

## Summary
- FDA requested ready-to-inject clinical vials instead of local formulation; company refiling IND.
- Patient enrollment now expected to begin in Q4 2021 (previously earlier timeline).
- Company states implementing FDA guidance adds benefit of controlling final drug product formulation.
- Press release dated July 23, 2021; IND filed June 29, 2021.

## SEC filing metadata
- accession: 0001493152-21-017696
- form_type: 8-K
- ticker: PTIX
- cik: 0001022899
- company_name: Protagenic Therapeutics, Inc.new
- filed_at: 2021-07-26T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1022899/000149315221017696/0001493152-21-017696-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1022899/000149315221017696/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-21-017696
- JSON: https://secwatch.observer/filing/0001493152-21-017696.json
- Plain text: https://secwatch.observer/filing/0001493152-21-017696.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.