---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-26-004739"
form_type: "8-K"
ticker: "MIRA"
cik: "0001904286"
company_name: "MIRA PHARMACEUTICALS, INC."
filed_at: "2026-02-02T23:59:59+00:00"
generated_at: "2026-05-16T05:45:38.939231+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# MIRA Pharma initiates final cohort of Ketamir-2 Phase 1 MAD trial; 50 volunteers dosed

## Summary
- Phase 1 MAD trial final cohort dosing underway; 50 healthy volunteers dosed, 6 remaining; completion expected by Q1 2026.
- Phase 2a proof-of-concept study for CIPN planned; protocol submission to FDA after Phase 1; targeting Q2 2026 start.
- Plans to pursue FDA Fast Track designation for Ketamir-2; to present Phase 1 data at AACR April 2026.
- Preclinical programs SKNY-1 (weight loss/nicotine addiction) and MIRA-55 (inflammatory pain) advancing toward IND-enabling by year-end 2026.
- Engaging in partnering discussions at BIO Partnering Investment & Growth Summit in March 2026.

## SEC filing metadata
- accession: 0001493152-26-004739
- form_type: 8-K
- ticker: MIRA
- cik: 0001904286
- company_name: MIRA PHARMACEUTICALS, INC.
- filed_at: 2026-02-02T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1904286/000149315226004739/0001493152-26-004739-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1904286/000149315226004739/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-26-004739
- JSON: https://secwatch.observer/filing/0001493152-26-004739.json
- Plain text: https://secwatch.observer/filing/0001493152-26-004739.txt

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