Company: MIRA
Filing Date: 2025-09-22
Form Type: 8-K
Source: 0001493152-25-014393
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-09-22
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Pharmaceuticals Announces Favorable Topline Results from Phase 1 SAD Study of Oral Ketamir-2, a Next-Generation Non-Scheduled Ketamine
Analog

Study
demonstrated that Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no
severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption and a favorable duration
of action supporting once-daily dosing.

On
September 22, 2025, MIRA Pharmaceuticals, Inc. (the “ Company”) announced topline results from the single ascending dose (SAD)
portion of its ongoing Phase 1 clinical trial evaluating oral Ketamir-2 in healthy volunteers.

The
randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg).
The primary endpoints were safety, tolerability, and pharmacokinetic (PK) characterization.

Pharmacokinetic
Results

  Dose-proportional                                                                                     
  increases in exposure (Cmax and AUC) were observed across all dose levels tested.                     
 ────────────────────────────────────────────────────────────────────────────────────────────────────────
  Median                                                                                                
  Terminal                                                                                              
  The                                                                                                   

Safety
and Tolerability Results

  Ketamir-2                                                                                                                          
  No                                                                                                                                 
  Reported                                                                                                                           
  Central                                                                                                                            

Next
Steps

Based
on the data, the Company is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers, to be followed
by a Phase 2a trial in patients with neuropathic pain.

Additional
Information

The
U. S. Drug Enforcement Administration’s scientific review of Ketamir-2 concluded that it would not be considered a controlled substance
or listed chemical under the Controlled Substances Act and its governing regulations.

SIGNATURES

Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.

                          MIRA                                          
  Dated:                  By:                        /s/                
                          Name:                      Erez               
                          Title:                     Chief