# EDGAR Filing Document

**Accession Number:** 0001904286
**File Stem:** 0001641172-25-021155
**Filing Date:** 2025-7
**Character Count:** 5863
**Document Hash:** f638f9cb4c2849d207f3a82bdfbaed97
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001641172-25-021155.hdr.sgml**: 20250728

**ACCESSION NUMBER**: 0001641172-25-021155

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20250728

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20250728

**DATE AS OF CHANGE**: 20250728

**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:** 251155493

**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 28, 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 |

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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 Pharmaceuticals Announces FDA Clearance of IND for Ketamir-2, Enabling U.S. Clinical Trials in Neuropathic Pain**

*Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion as the Company prepares to launch U.S. Phase 2a by year-end*

 

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Ketamir-2, the Company's novel oral NMDA receptor antagonist for the treatment of neuropathic pain. The clearance enables MIRA to initiate U.S.-based clinical trials.

The IND submission included preclinical data demonstrating potent analgesic effects and a favorable safety profile across validated models of diabetic, chemotherapy-induced, and nerve ligation-associated neuropathy. Ketamir-2 showed superior efficacy to gabapentin and pregabalin in head-to-head studies and no evidence of ketamine-associated neurotoxicity.

Ketamir-2 achieved good oral bioavailability and efficient blood-brain barrier penetration, supported by its non-P-gp substrate status. Preclinical studies further showed antidepressant- and anxiolytic-like effects with no dissociative or psychotomimetic side effects.

The Company is nearing completion of the single ascending dose (SAD) portion of its international Phase 1 trial and is preparing to initiate the multiple ascending dose (MAD) portion. MIRA plans to initiate its U.S.-based Phase 2a efficacy trial in the fourth quarter of 2025.

In addition, MIRA continues to advance two other key programs. The Company's planned acquisition of SKNY Pharmaceuticals, Inc. remains on track, with SKNY-1 showing robust preclinical efficacy in obesity and nicotine craving models, as well as reversal of anxiety-like behavior. Separately, MIRA-55, an oral cannabinoid analog, has demonstrated comparable efficacy to morphine in inflammatory pain models and is under evaluation for further development.

**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 28, 2025 | By: | */s/ Erez Aminov* |
|  | Name: | Erez Aminov |
|  | Title: | Chief Executive Officer |

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