Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-032777

Filed: 2026-07-10

Period: 2026-07-10

CIK: 0001904286

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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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 10, 2026

MIRA

PHARMACEUTICALS, INC.

(Exact

Name of Registrant as Specified in its Charter)

Florida

001-41765

85-3354547

(State

or Other Jurisdiction

(Commission

(IRS

Employer

Incorporation)

File

Number)

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:

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 ☒

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

7.01 Regulation FD Disclosure.

July 10, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from preclinical

studies evaluating optimized oral formulations of MIRA-55, the Company’s oral drug candidate being developed as a non-opioid therapy

for chronic inflammatory pain.

Following

evaluation of multiple oral formulations, the Company selected a lead formulation demonstrating favorable oral bioavailability together

with sustained systemic exposure and reproducible distribution into both brain and liver tissue following oral administration. The study

included an intravenous reference arm to characterize absolute oral bioavailability and support selection of the lead formulation based

on its overall pharmacokinetic profile.

The

Company believes these pharmacokinetic findings further strengthen the development profile of MIRA-55 by demonstrating that the optimized

oral formulation provides meaningful systemic exposure together with distribution into pharmacologically relevant tissues related to

both central and peripheral mechanisms of chronic inflammatory pain. These findings build upon the Company’s previously reported

preclinical studies demonstrating that oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model,

outperforming injected morphine, while also exhibiting a differentiated pharmacological profile relative to THC. In separate mechanistic

and behavioral studies, MIRA-55 demonstrated anxiolytic activity, did not produce the characteristic central nervous system effects associated

with THC, and was shown to interact with the cannabinoid system through a mechanism distinct from THC.

copy of the Company’s press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The

information contained in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes

of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities

of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the

Exchange Act, except as expressly set forth by specific reference in such filing.

Item

9.01 Financial Statements and Other Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release of MIRA Pharmaceuticals, Inc., dated July 10, 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document)

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

PHARMACEUTICALS, INC.

Dated:

July 10, 2026

By:

/s/

Erez Aminov

Name:

Erez

Aminov

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

MIRA

Pharmaceuticals Reports Successful Formulation Results Supporting Development of MIRA-55 as a Non-Opioid Oral Therapy for Chronic Inflammatory

Pain

Optimized

Oral Formulation Demonstrates Favorable Oral Bioavailability Together with Robust Brain and Liver Distribution Following Oral Administration

MIAMI,

FL / ACCESS Newswire / July 10, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),

a clinical-stage pharmaceutical company, today announced positive results from preclinical studies evaluating optimized oral formulations

of MIRA-55, the Company’s oral drug candidate being developed as a non-opioid therapy for chronic inflammatory pain.

Following

evaluation of multiple oral formulations, the Company selected a lead formulation demonstrating favorable oral bioavailability together

with sustained systemic exposure and reproducible distribution into both brain and liver tissue following oral administration. Collectively,

these findings support the continued development of MIRA-55 as an orally administered therapy for chronic inflammatory pain.

“Patients

deserve safer and more effective non-opioid treatment options for chronic inflammatory pain,” said Erez Aminov, Chief Executive

Officer of MIRA Pharmaceuticals. “These formulation and pharmacokinetic findings represent another important step in advancing

MIRA-55 as a differentiated oral therapy designed to address that need.”

The

objective of the study was to optimize the oral formulation of MIRA-55 by comparing multiple formulations in a preclinical pharmacokinetic

study. An intravenous reference arm was included to characterize absolute oral bioavailability and support selection of the lead formulation

based on its overall pharmacokinetic profile.

The

selected formulation demonstrated reproducible distribution into both brain and liver tissue following oral administration. Brain exposure

may support modulation of central pain-processing pathways, while peripheral distribution may contribute to the anti-inflammatory activity

previously observed in MIRA’s preclinical efficacy studies. Together, these findings demonstrate that the optimized formulation

successfully delivers MIRA-55 to pharmacologically relevant tissues associated with both central and peripheral mechanisms of chronic

inflammatory pain.

“Formulation

optimization is far more than a pharmaceutical exercise—it is what enables a molecule to consistently engage its intended biological

targets,” said Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA Pharmaceuticals. “The combination of favorable

oral exposure together with reproducible brain and peripheral tissue distribution provides important support for MIRA-55’s proposed

mechanism of action and its continued development as an oral therapy for chronic inflammatory pain.”

Today’s

pharmacokinetic findings build upon MIRA’s previously reported preclinical studies demonstrating that oral MIRA-55 normalized pain

and reduced inflammation in a validated inflammatory pain model, outperforming injected morphine, while also exhibiting a differentiated

pharmacological profile relative to THC. In separate mechanistic and behavioral studies, MIRA-55 demonstrated anxiolytic activity, did

not produce the characteristic central nervous system effects associated with THC, and was shown to interact with the cannabinoid system

through a mechanism distinct from THC. Collectively, these efficacy, behavioral, mechanistic, and pharmacokinetic findings continue to

strengthen the overall development package supporting MIRA-55 as a differentiated oral therapeutic candidate for chronic inflammatory

pain.

The

Company plans to continue evaluating the relationship between tissue exposure, pharmacodynamic activity, and therapeutic efficacy as

MIRA-55 advances through additional preclinical development.

About

Mira-55

is a next-generation cannabinoid analog designed to modulate cannabinoid receptor activity, including CB1 and CB2 pathways, while minimizing

CB1-related psychoactivity. Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not

classified as a controlled substance.

About

MIRA Pharmaceuticals, Inc.

MIRA

Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics for

neurologic, inflammatory, metabolic, and neuropsychiatric disorders. The Company’s pipeline includes Ketamir-2, an investigational

oral therapy that successfully completed a Phase 1 clinical trial and for which the Company has submitted a Phase 2a protocol to the

U.S. Food and Drug Administration (FDA) under its active U.S. Investigational New Drug (IND) application for chemotherapy-induced peripheral

neuropathy (CIPN); MIRA-55, a preclinical oral drug candidate being developed for chronic inflammatory pain; and SKNY-1,

a preclinical oral drug candidate being developed for obesity and addiction-related disorders.

Cautionary

Note Regarding Forward-Looking Statements

This

press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of

1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,”

“plan,” “can,” “could,” “would,” “may,” “will,” “believe,”

“estimate,” “forecast,” “goal,” “project,” “guidance,” “potential,”

“intend,” “seek,” “target” and other words of similar meaning, although not all forward-looking statements

include these words. Forward-looking statements may include, but are not limited to, statements regarding the development of SKNY-1;

its potential efficacy, safety, tolerability, pharmacokinetic profile, tissue distribution, mechanism of action, and therapeutic benefits;

the potential advantages of SKNY-1 compared to existing treatment options; the potential for once-daily oral dosing; the preservation

of lean body mass; future preclinical studies; future clinical development; regulatory interactions; intellectual property protection;

strategic partnership opportunities; and the future development and commercialization of SKNY-1. Forward-looking statements are based

on current expectations, estimates, forecasts, and projections, as well as management’s beliefs and assumptions, and are subject

to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements.

These

risks and uncertainties include, among others, risks related to preclinical and clinical development; the ability to obtain regulatory

approvals; the outcome of future studies; reliance on third parties; intellectual property protection; financing needs; market conditions;

and the other risks identified under the heading “Risk Factors” contained in the Company’s Annual Report on Form 10-K

and the Company’s other filings with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking statements

contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements,

whether as a result of new information, future events, or otherwise, except as required by applicable law.

caution investors not to place undue reliance on the forward-looking statements contained in this press release. Investors are encouraged

to review the Company’s filings with the SEC, available at www.sec.gov, and in the Investors section of the Company’s

website at www.mirapharma.com, for a discussion of these and other risks and uncertainties.

Contact

Krystina Quintana

MIRA Pharmaceuticals, Inc.

info@mirapharma.com

(786) 432-9792

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