Company: MIRA
Filing Date: 2025-07-02
Form Type: 8-K
Source: 0001641172-25-017557
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Company: MIRA PHARMACEUTICALS, INC.
Filing Date: 2025-07-02
Form: 8-K
Item: Item 8.01
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Item
8.01 Other Events

MIRA
Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid
Risks

On
July 2, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“ MIRA” or the “ Company”) announced preclinical results
demonstrating that its proprietary drug candidate, Mira-55 morphine-comparable
pain relief animal model of inflammatory pain

Mira-55
is a synthetic analog of marijuana engineered to selectively activate CB2 receptors efficacy
comparable to morphine

In
addition, the Company previously received confirmation from the U. S. Drug Enforcement Administration (DEA) Mira-55 is
not classified as a controlled substance

These
new results strengthen MIRA’s pain-focused pipeline by positioning Mira-55 as a complementary program to Ketamir-2 Phase 1 development neuropathic pain

“ With
Mira-55 and Ketamir-2, we believe we’re building a differentiated, non-opioid pain franchise with the potential to treat two of
the largest and most underserved pain markets,” said Erez Aminov, Chairman and CEO of MIRA.

MIRA
also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational
therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without
muscle loss, along with a reversal of nicotine cravings - highlighting its potential as a differentiated treatment in two major markets.
The U. S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed
with shareholder approval and the final steps toward completing the transaction.

MIRA
continues to advance Mira-55 toward an Investigational New Drug (IND) submission

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