Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-036262

Filed: 2026-08-06

Period: 2026-08-06

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): August 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.

August 6, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive toxicokinetic findings

from a 7-day repeated-dose study of SKNY-1 in Beagle dogs. SKNY-1 is an investigational oral drug candidate being developed for obesity,

which aims to preserve lean body mass while promoting weight reduction.

The

study evaluated SKNY-1 following repeated daily oral dosing in male and female Beagle dogs over 7 days. SKNY-1 demonstrated rapid oral

absorption and dose-dependent systemic exposure across the evaluated dose range. Plasma concentrations were comparable between male and

female animals. The data demonstrates evidence of dose-dependent response and systemic accumulation with repeated dosing, providing confidence

in dose selection for the planned GLP toxicology program.

The

Company believes these toxicokinetic findings de-risk dose selection and support advancement toward GLP-compliant toxicology studies

required for IND-enabling development. These findings are based on preclinical toxicokinetic studies, and additional preclinical efficacy

and safety studies will be required to further characterize SKNY-1 as the Company advances its IND-enabling program. A copy of the press

release is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The

information 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 in 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.

Cautionary

Note Regarding Forward-Looking Statements

This

report contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995.

These forward-looking statements generally may 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 therapeutic potential,

mechanism of action, development plans, regulatory pathway, safety profile, efficacy, anticipated clinical development, commercialization

prospects, market opportunity, and future development of MIRA-55, SKNY-1, Ketamir-2, and the Company’s other product candidates.

These

forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management’s current

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 subsequent filings with the U.S. Securities and Exchange

Commission (“SEC”).

Forward-looking

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

these forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable

law.

Investors

are cautioned not to place undue reliance on these forward-looking statements. Additional information regarding these and other risks

and uncertainties is contained in the Company’s filings with the SEC, including its Annual Report on Form 10-K and subsequent filings,

available at www.sec.gov and in the Investors section of the Company’s website at www.mirapharmaceuticals.com. Forward-looking

statements should be considered in light of these risks and uncertainties.

Item

9.01 Financial Statements and Other Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release of MIRA Pharmaceuticals, Inc., dated August 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: August 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

Reports Positive 7-Day Dog Study Results for SKNY-1—Obesity Treatment Designed to Preserve Lean Body Mass

Toxicokinetic

Findings De-Risk Dose Selection and Support Regulatory Pathway Toward IND

MIAMI,

August 6, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or

the “Company”), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced

positive toxicokinetic findings from a 7-day repeated-dose study of SKNY-1 in Beagle dogs. The study demonstrates dose-dependent systemic

exposure and rapid absorption that de-risk dose selection and support advancement toward GLP toxicology studies and IND-enabling development.

The

study evaluated SKNY-1 following repeated daily oral dosing in male and female Beagle dogs over 7 days. SKNY-1 demonstrated rapid oral

absorption and dose-dependent systemic exposure across the evaluated dose range. Plasma concentrations were comparable between male and

female animals.

The

data demonstrates evidence of dose-dependent response and systemic accumulation with repeated dosing, providing confidence in dose selection

for the planned GLP toxicology program.

“Obesity

treatments today often come at the cost of lean muscle loss, which undermines long-term health outcomes,” said Erez Aminov, Chairman

and Chief Executive Officer of MIRA Pharmaceuticals. “SKNY-1 aims to solve that problem. These toxicokinetic findings de-risk our

dose selection, and we’re excited to continue advancing SKNY-1 toward IND-enabling development.”

Dr.

Itzchak Angel, Chief Scientific Advisor of MIRA, added: “Characterizing systemic exposure in a larger animal species is essential

for translating to humans. The dose-dependent relationship and rapid absorption in dogs further strengthen our development package and

support advancement toward GLP toxicology studies.”

These

toxicokinetic findings will inform dose selection and study design for the Company’s planned GLP-compliant toxicology program.

MIRA is advancing SKNY-1 through additional preclinical efficacy and safety studies to build a comprehensive nonclinical package supporting

IND-enabling development for obesity.

About

SKNY-1

peer-reviewed preclinical studies published in the International Journal of Molecular Sciences, oral SKNY-1 demonstrated dose-dependent

reductions in body weight while preserving lean body mass, along with lipid normalization and reduced hepatic triglyceride accumulation.

The compound attenuated compulsive feeding behavior in validated experimental models. In separate behavioral studies, SKNY-1 was devoid

of anxiety-related effects despite engaging central cannabinoid pathways, distinguishing it from earlier CB1-targeting therapies. A lead

oral formulation demonstrated favorable bioavailability with robust brain penetration and substantial liver exposure, supporting once-daily

oral dosing potential.

About

MIRA Pharmaceuticals, Inc.

MIRA

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

Company’s pipeline includes Ketamir-2 for chemotherapy-induced peripheral neuropathy (CIPN), which has completed Phase 1 and is

advancing toward Phase 2a under an active IND; MIRA-55, an investigational oral drug candidate for chronic inflammatory pain; and SKNY-1,

an investigational oral drug candidate for obesity. Following scientific review, the U.S. Drug Enforcement Administration has determined

that Ketamir-2, MIRA-55 and SKNY-1 are not classified as controlled substances.

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 may 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 therapeutic potential,

mechanism of action, development plans, regulatory pathway, safety profile, efficacy, anticipated clinical development, commercialization

prospects, market opportunity, and future development of MIRA-55, SKNY-1, Ketamir-2, and the Company’s other product candidates.

These

forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management’s current

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 subsequent filings with the U.S. Securities and Exchange

Commission (“SEC”).

Forward-looking

statements contained in this press release speak only as of the date of this press release, and the Company undertakes no obligation

to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as

required by applicable law.

Investors

are cautioned not to place undue reliance on these forward-looking statements. Additional information regarding these and other risks

and uncertainties is contained in the Company’s filings with the SEC, including its Annual Report on Form 10-K and subsequent filings,

available at www.sec.gov and in the Investors section of the Company’s website at www.mirapharmaceuticals.com.

Forward-looking statements should be considered in light of these risks and uncertainties.

Contact:

Krystina

Quintana

MIRA Pharmaceuticals

info@mirapharma.com

(786) 432-9792

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