# EDGAR Filing Document

**Accession Number:** 0001904286
**File Stem:** 0001641172-25-017557
**Filing Date:** 2025-7
**Character Count:** 6669
**Document Hash:** d304f70bc9a3099f562b450ea54c00a9
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001641172-25-017557.hdr.sgml**: 20250702

**ACCESSION NUMBER**: 0001641172-25-017557

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250702

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20250702

**DATE AS OF CHANGE**: 20250702

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** MIRA PHARMACEUTICALS, INC.
- **CENTRAL INDEX KEY:** 0001904286
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 853354547
- **STATE OF INCORPORATION:** FL

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41765
- **FILM NUMBER:** 251100944

**BUSINESS ADDRESS:**
- **STREET 1:** 1200 BRICKELL AVENUE
- **STREET 2:** SUITE 1950 #1183
- **CITY:** MIAMI
- **STATE:** FL
- **ZIP:** 33131
- **BUSINESS PHONE:** 813-369-5150

**MAIL ADDRESS:**
- **STREET 1:** 324 SOUTH HYDE PARK AVENUE, SUITE 350
- **CITY:** TAMPA
- **STATE:** FL
- **ZIP:** 33606

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Mira1a Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20220112

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported): July 2, 2025**

**MIRA PHARMACEUTICALS, INC.**

**(Exact Name of Registrant as Specified in its Charter)**

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| | | |
|:---|:---|:---|
| **Florida** | **001-41765** | **85-3354547** |
| **(State or Other Jurisdiction<br> of Incorporation)** | **(Commission** <br> **File Number)** | **(IRS Employer<br> Identification No.)** |

---

**1200 Brickell Avenue, Suite 1950 #1183 Miami, Florida 33131 (Address of Principal Executive Offices)**

**Registrant's telephone number, including area code: (786) 432-9792**

**Not Applicable**

**(Former Name or Former Address, if Changed Since Last Report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

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| | | |
|:---|:---|:---|
| Title of each class | Trading Symbol | Name of each exchange on which registered |
| Common Stock, $0.0001 par value per share | MIRA | The Nasdaq Capital Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**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**, a non-psychoactive marijuana analog, delivered **morphine-comparable pain relief** in a validated **animal model of inflammatory pain**, without inducing local inflammation.

Mira-55 is a synthetic analog of marijuana engineered to selectively activate **CB2 receptors**, which are associated with anti-inflammatory and analgesic effects. Unlike THC, it exhibits minimal activity at CB1 receptors, thus avoiding psychoactive side effects. In a formalin-based rodent model, Mira-55 significantly reduced pain sensitivity, restored pain thresholds to near-baseline levels, and showed **efficacy comparable to morphine**, the opioid control. No sedative or inflammatory effects were observed.

In addition, the Company previously received confirmation from the **U.S. Drug Enforcement Administration (DEA)** that **Mira-55 is not classified as a controlled substance**, removing a key regulatory barrier to clinical development.

These new results strengthen MIRA's pain-focused pipeline by positioning Mira-55 as a complementary program to **Ketamir-2**, the Company's clinical-stage NMDA receptor antagonist currently progressing through **Phase 1 development** for **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**, with development efforts supporting future clinical trials in inflammatory pain indications.

**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.

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| | | |
|:---|:---|:---|
|  | **MIRA PHARMACEUTICALS, INC.** | **MIRA PHARMACEUTICALS, INC.** |
| Dated: July 2, 2025 | By: | */s/ Erez Aminov* |
|  | Name: | Erez Aminov &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; |
|  | Title: | Chief Executive Officer |

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