# EDGAR Filing Document

**Accession Number:** 0001904286
**File Stem:** 0001493152-25-018141
**Filing Date:** 2025-10
**Character Count:** 6416
**Document Hash:** 64b6b1e85e3f80cd8ec58914e706c4c6
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-018141.hdr.sgml**: 20251015

**ACCESSION NUMBER**: 0001493152-25-018141

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20251015

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20251015

**DATE AS OF CHANGE**: 20251015

**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:** 251394828

**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): October 15, 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 Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain**

*Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA's position in a $70 billion non-opioid pain market.*

On October 15, 2025, **MIRA Pharmaceuticals, Inc.** (the "Company") announced new **preclinical data** for **Mira-55**, its proprietary non-psychotropic marijuana analog, showing that **oral administration of Mira-55 normalized pain and significantly reduced inflammation**, outperforming **injected morphine** in an established animal model of chronic inflammatory pain.

This study marks the first time **inflammation was directly measured** alongside pain in the Mira-55 program. In the Company's prior study, only pain sensitivity was assessed, with both Mira-55 and morphine administered by injection. The new data demonstrate that **orally administered Mira-55 provided superior pain normalization and direct anti-inflammatory effects**, while morphine produced only partial and indirect inflammation reduction.

**Key observations from the study include:**

● **Pain normalization:** Oral Mira-55 restored pain thresholds to baseline levels and outperformed injected morphine in reversing formalin-induced pain sensitivity.

● **Inflammation reduction:** Mira-55 significantly reduced paw edema, confirming a **direct CB2-receptor-mediated anti-inflammatory mechanism**, whereas morphine reduced swelling only partially through indirect, centrally mediated effects.

● **Oral advantage:** Mira-55's efficacy via oral administration highlights a potential clinical convenience compared with morphine, which required injection to achieve its effects.

**Reducing inflammation is fundamental to treating pain effectively.** Inflammation drives nerve sensitization and amplifies pain signaling. Opioids block pain perception in the brain but do not treat inflammation, while NSAIDs address inflammation but carry safety concerns. By directly targeting inflammation through CB2 receptor activation, Mira-55 addresses both the cause and the perception of pain, offering a differentiated dual mechanism for chronic inflammatory pain conditions.

These findings support the Company's plan to pursue an **Investigational New Drug (IND)** application for chronic inflammatory pain and strengthen the scientific basis for advancing Mira-55 within its non-opioid pain franchise.

**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: October 15, 2025 | By: | */s/ Erez Aminov* |
|  | Name: | Erez Aminov |
|  | Title: | Chief Executive Officer |

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