secwatch.observer — SEC 8-K summary
======================================

Issuer:     MIRA PHARMACEUTICALS, INC. (MIRA)
CIK:        0001904286
Form:       8-K
Filed at:   2025-03-04T23:59:59+00:00
Accession:  0001493152-25-008977
Event type: other_material
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

MIRA Pharma receives Israeli MoH approval to start Phase 1 trial for Ketamir-2 in neuropathic pain
--------------------------------------------------------------------------------

- Approval from Israeli Ministry of Health and IRB to initiate Phase 1 trial for Ketamir-2, an oral ketamine analog.
- Randomized, double-blind, placebo-controlled study evaluating safety, tolerability, and PK in healthy volunteers at Hadassah Medical Center.
- Subject recruitment begins Q1 2025; Phase 1 expected to conclude Q4 2025, followed by Phase 2a in neuropathic pain patients by year-end.
- Awaiting neurotoxicity study results from FDA, expected Q2 2025, to enable IND and U.S. patient dosing.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1904286/000149315225008977/0001493152-25-008977-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1904286/000149315225008977/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-25-008977

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer