# EDGAR Filing Document

**Accession Number:** 0001904286
**File Stem:** 0001493152-25-019065
**Filing Date:** 2025-10
**Character Count:** 7360
**Document Hash:** 98b10ac327447a80527752bd783eccfe
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-019065.hdr.sgml**: 20251023

**ACCESSION NUMBER**: 0001493152-25-019065

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 12

**CONFORMED PERIOD OF REPORT**: 20251023

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20251023

**DATE AS OF CHANGE**: 20251023

**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:** 251412996

**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 23, 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.)** |

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**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 Initiates Multiple Ascending Dose (MAD) Phase 1 Study of Oral Ketamir-2 and Selects Chemotherapy-Induced Neuropathic Pain as Lead Phase 2a Indication**

**Advancing toward Phase 2a clinical evaluation in chemotherapy-related pain, a condition with no approved treatments and potential for FDA Fast Track consideration**

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company") announced that it has initiated the multiple ascending dose (MAD) portion of its ongoing Phase 1 clinical trial, evaluating its lead oral candidate, Ketamir-2, in healthy volunteers. The Company also announced that it has selected chemotherapy-induced peripheral neuropathy (CIPN) as the lead indication for its planned Phase 2a clinical evaluation.

This milestone follows the completion of dosing in the single ascending dose (SAD) portion of the study. According to data reviewed to date, no serious or dose-limiting adverse events were observed, and no clinically significant safety concerns have been reported. Comprehensive pharmacokinetic analyses will be performed following unblinding to further characterize Ketamir-2's absorption and half-life profile. The ongoing randomized, double-blind, placebo-controlled Phase 1 study is evaluating single and multiple oral doses of Ketamir-2 to assess its safety, tolerability, and pharmacokinetics in healthy volunteers. The MAD portion includes three cohorts of repeat daily oral dosing ranging from 150 mg to 600 mg for five days, building on the safety and PK data from the SAD phase.

Ketamir-2's advancement is supported by a growing body of preclinical and peer-reviewed research demonstrating activity in validated neuropathic pain models. In these studies, Ketamir-2 outperformed ketamine, gabapentin, and pregabalin in reducing pain behaviors and restoring sensory function across several models of neuropathic pain. In the paclitaxel chemotherapy-induced neuropathy model, Ketamir-2 produced near complete normalization of pain sensitivity and demonstrated greater efficacy than gabapentin, an FDA-approved standard for neuropathic pain.

Chemotherapy-induced peripheral neuropathy (CIPN) is a painful nerve damage condition caused by certain chemotherapy drugs that can result in persistent pain, tingling, numbness, and burning sensations, most commonly in the hands and feet. It affects a large percentage of cancer patients during treatment and often continues after therapy ends, frequently impacting quality of life and treatment continuity. Despite its prevalence, there are no FDA-approved therapies for CIPN. The Company believes that Ketamir-2's pharmacologic profile and preclinical results support its further development as a potential non-opioid therapy for this indication.

Ketamir-2 is a novel, non-scheduled oral analog of ketamine engineered to overcome limitations associated with ketamine use, including the need for intravenous administration, short duration of action, and undesirable psychoactive effects. The drug has good oral absorption and is adapted for once-daily dosing without hallucinogenic or dissociative effects. Given the absence of FDA-approved treatments for chemotherapy-induced neuropathic pain and the significant medical unmet need in oncology supportive care, the Company believes Ketamir-2 may qualify for consideration of regulatory incentives such as Fast Track designation.

**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 23, 2025 | By: | */s/ Erez Aminov&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;* |
|  | Name: | Erez Aminov |
|  | Title: | Chief Executive Officer |

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