Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-032091

Filed: 2026-07-06

Period: 2026-07-06

CIK: 0001904286

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

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EX-99.1 (ex99-1.htm)

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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 6, 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 6, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from preclinical

studies evaluating the optimized oral formulation of SKNY-1, the Company’s oral drug candidate being developed for obesity and

addiction-related disorders.

The

studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial

liver exposure following oral administration. Peak plasma concentrations and kinetics supported the potential for convenient once-daily

oral dosing.

The

Company believes these pharmacokinetic findings further strengthen the development profile of SKNY-1 by demonstrating that the optimized

oral formulation delivers meaningful systemic exposure together with distribution into pharmacologically relevant tissues. These findings

complement the Company’s previously reported preclinical efficacy and behavioral studies demonstrating significant reductions in

body weight, preservation of lean body mass, improvements in metabolic parameters, attenuation of compulsive feeding and nicotine-seeking

behaviors, and evidence that SKNY-1 did not produce anxiety-related behavioral effects in a validated preclinical

model despite demonstrated cannabinoid receptor activity.

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 6, 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 6, 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 for SKNY-1, its Oral Drug Candidate for Obesity and Addiction

New

Preclinical Data Demonstrate Favorable Oral Bioavailability, Robust Brain Penetration and Liver Exposure with Once-Daily Dosing Potential

MIAMI,

FL / ACCESS Newswire / July 6, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),

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

of SKNY-1, the Company’s oral drug candidate being developed for obesity and addiction-related disorders.

The

studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial

liver exposure following oral administration. Peak plasma concentrations were observed approximately six to twelve hours after dosing,

supporting the potential for convenient once-daily oral dosing. Collectively, these findings further strengthen the development profile

of SKNY-1 by demonstrating that the compound combines meaningful pharmacologic activity observed in previously reported efficacy studies

with pharmacokinetic characteristics that support continued development as an orally administered therapeutic.

“We

believe the next generation of obesity therapies should not only help patients lose weight, but also preserve lean body mass, support

long-term metabolic health, and provide the convenience of oral administration,” said Erez Aminov, CEO of MIRA. “These

formulation and pharmacokinetic findings further strengthen our confidence in SKNY-1 as a differentiated oral drug candidate designed

to address both obesity and addiction through a novel mechanism.”

The

objective of the study was to optimize the oral formulation of SKNY-1 and evaluate its pharmacokinetic profile, oral bioavailability,

and tissue distribution following oral administration. Multiple oral formulations were evaluated in a preclinical pharmacokinetic study

to identify an optimized formulation that provides reproducible systemic exposure together with meaningful distribution into pharmacologically

relevant target tissues.

Importantly,

SKNY-1 demonstrated robust brain penetration and substantial liver exposure following oral administration. Detectable tissue exposure

was consistently observed across multiple animals, supporting reliable and reproducible distribution into target organs.

The

simultaneous exposure of both the central nervous system and liver is particularly significant because these organs regulate complementary

aspects of appetite, reward signaling, and metabolic homeostasis. Brain penetration may support modulation of neuronal circuits involved

in appetite, satiety, and reward-associated behaviors, while liver exposure may contribute to regulation of lipid metabolism, glucose

homeostasis, and energy utilization previously observed in preclinical efficacy studies.

Importantly,

robust brain penetration was achieved while maintaining a differentiated central nervous system profile. As previously reported by the

Company, SKNY-1 was devoid of anxiety-related behavior in a validated preclinical cannabinoid behavioral model despite engaging central

cannabinoid pathways. These findings distinguish SKNY-1 from earlier CB1-targeting therapies, including rimonabant, which were associated

with significant neuropsychiatric adverse effects.

SKNY-1

was designed with a differentiated pharmacological profile combining biased CB1 receptor modulation, partial CB2 receptor agonism, and

selective MAO-B inhibition without MAO-A inhibition. The Company believes this differentiated pharmacology may allow engagement of central

pathways involved in appetite regulation and reward signaling while potentially avoiding the psychiatric limitations that restricted

earlier CB1-targeting therapies.

“Earlier

CB1-targeting therapies demonstrated the importance of the pathway, but their development was ultimately limited by neuropsychiatric

side effects,” said Itzchak Angel, Ph.D., CSA of MIRA. “The combination of robust brain penetration together with

our previously reported behavioral findings reinforces the differentiated pharmacological profile of SKNY-1 and supports its continued

development as a potential next-generation therapy targeting the endocannabinoid system.”

The

pharmacokinetic findings complement MIRA’s recently published peer-reviewed preclinical studies demonstrating that SKNY-1 produced

significant reductions in body weight, preserved lean body mass, improved lipid parameters, reduced hepatic triglyceride accumulation,

and attenuated compulsive feeding and nicotine-seeking behaviors in validated experimental models of obesity. Taken together, the efficacy,

behavioral, mechanistic, and pharmacokinetic findings continue to strengthen the overall development package supporting SKNY-1 as a differentiated

oral therapeutic candidate.

Key

Study Highlights

● Optimized

oral formulation demonstrated favorable oral bioavailability following oral administration.

● Pharmacokinetic

profile supports the potential for convenient once-daily oral dosing.

● Robust

brain penetration and substantial liver exposure following oral administration.

● Reproducible

systemic exposure and target tissue distribution across multiple animals.

● Findings

complement previously reported efficacy, behavioral, mechanistic, and pharmacokinetic studies

supporting SKNY-1’s differentiated development profile.

The

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

SKNY-1 advances through additional preclinical development.

About

SKNY-1

is an orally administered investigational drug candidate designed to modulate multiple pathways associated with metabolic regulation

and reward-associated behaviors. The compound was designed to combine pathway-selective CB1 modulation, CB2 receptor activity, and selective

MAO-B inhibition. In preclinical studies, oral administration of SKNY-1 was associated with dose-dependent reductions in body weight

and lipid normalization, with no significant reduction in whole-body density observed during the treatment period - a finding relevant

in the context of ongoing clinical focus on lean body mass preservation during weight reduction. SKNY-1 has not been approved by the

U.S. Food and Drug Administration (FDA) or any other regulatory authority, and its safety and efficacy have not been established in humans.

About

MIRA Pharmaceuticals, Inc.

MIRA

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

serious 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 therapy being developed for chronic inflammatory pain; and SKNY-1,

a preclinical oral small-molecule 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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