Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-048978

Filed: 2026-10-28

Period: 2026-10-28

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): October 28, 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.

MIRA

Pharmaceuticals Reports Significant Weight and Fat Reduction With Oral SKNY-1 in Obese Mice, Showing Favorable Lean-Mass and Weight-Regain

Outcomes Compared With Semaglutide

October 28, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) announced initial positive proof-of-concept results from an

exploratory pilot study evaluating SKNY-1, its investigational oral drug candidate for obesity and metabolic disorders.

Conducted

in an established diet-induced obesity (DIO) mouse model, the study demonstrated statistically significant reductions in body weight

and fat mass following oral administration of SKNY-1 compared with vehicle-treated controls. The study also identified three potentially

meaningful areas of differentiation from the semaglutide reference group:

1. Food

Intake: Weight reduction occurred without a statistically significant decrease in food

consumption, raising the possibility that SKNY-1 may influence metabolic pathways beyond

appetite suppression. Following treatment discontinuation, oral SKNY-1-treated groups showed

no statistically significant increase in food consumption relative to vehicle controls, while

semaglutide-treated mice demonstrated a statistically significant increase.

2. Lean-Mass

Outcomes: Oral SKNY-1-treated mice did not demonstrate statistically significant lean-mass

loss relative to vehicle controls, while semaglutide-treated mice demonstrated statistically

significant lean-mass loss compared with vehicle-treated controls.

3. Weight

Regain Following Treatment Discontinuation: Oral SKNY-1-treated mice demonstrated slow

and limited weight regain during the two-week observation period following treatment cessation,

contrasting with rapid and substantial weight rebound in semaglutide-treated mice.

copy of the Company’s press release, scheduled for distribution on October

29, 2026, is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is 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, 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 Securities Exchange Act of

1934, as amended, 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 October 29, 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:

October 28, 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 Significant Weight and Fat Reduction With Oral SKNY-1 in Obese Mice, Showing Favorable Lean-Mass and Weight-Regain

Outcomes Compared With Semaglutide

SKNY-1’s

Weight Reduction Without Significant Changes in Food Consumption Suggests a Potential Role for Energy Expenditure, Contrasting With Semaglutide’s

Initial Food-Intake Suppression and Significant Post-Treatment Increase

MIAMI,

Oct. 29, 2026 (GLOBE NEWSWIRE) — MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),

a clinical-stage pharmaceutical company developing novel oral therapeutics, today announced initial positive proof-of-concept results

from an exploratory pilot study evaluating SKNY-1, its investigational oral drug candidate for obesity and metabolic disorders.

Conducted

in an established diet-induced obesity (DIO) mouse model, the study demonstrated statistically significant reductions in body weight

and fat mass following oral administration of SKNY-1 compared with vehicle-treated controls.

Importantly,

weight reduction occurred without a statistically significant decrease in food consumption, raising the possibility that SKNY-1 may influence

metabolic pathways beyond appetite suppression.

The

study also identified three potentially meaningful areas of differentiation from the semaglutide reference group: effects on food intake,

lean-mass outcomes, and weight regain following treatment discontinuation. Together, these findings expand upon previous SKNY-1 research

and support its continued development as a potentially differentiated oral approach to weight management.

“Obesity

represents one of the largest and fastest-growing opportunities in healthcare, with the potential for multiple multibillion-dollar therapies,”

said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. “We believe the future of obesity treatment will extend

beyond a single class of drugs. Patients have different needs, and there is tremendous opportunity for innovative therapies that work

through distinct mechanisms and offer favorable profiles for long-term weight management. What makes SKNY-1 particularly exciting is

that our findings point toward a potentially differentiated metabolic approach, with encouraging signals regarding body composition and

weight maintenance following treatment discontinuation. We believe these characteristics could become important advantages as we continue

advancing SKNY-1, positioning it as a potentially valuable asset within our pipeline and an opportunity to participate in this significant

global market.”

Key

Findings From the SKNY-1 Pilot Study

Statistically

Significant Weight and Fat Reduction

Oral

SKNY-1 demonstrated statistically significant reductions in body weight and fat mass compared with vehicle-treated controls. The majority

of the treatment-associated weight difference was attributable to fat reduction, providing encouraging evidence of SKNY-1’s activity

in an established obesity model.

Favorable

Lean-Mass Findings Compared With the Semaglutide Reference Group

the Day 14 body-composition assessment, oral SKNY-1-treated mice did not demonstrate statistically significant lean-mass loss relative

to vehicle controls.

contrast, semaglutide-treated mice demonstrated statistically significant lean-mass loss compared with vehicle-treated controls.

Limited

Weight Regain Following Treatment Discontinuation Compared With Semaglutide

During

the two-week observation period following treatment cessation, oral SKNY-1-treated mice demonstrated slow and limited weight regain.

contrast, semaglutide-treated mice experienced rapid and substantial weight rebound, which was accompanied by a statistically significant

increase in food consumption relative to vehicle controls, while oral SKNY-1-treated groups showed no statistically significant increase

in food consumption.

Investigating

a Potentially Differentiated Metabolic Mechanism

The

study’s findings raise the possibility that SKNY-1 may influence energy expenditure, energy utilization, or other metabolic pathways

involved in weight regulation, rather than relying primarily on appetite suppression.

These

observations provide a scientific rationale for investigating SKNY-1’s potentially differentiated metabolic mechanism.

“One

of the most intriguing findings from this pilot study is that SKNY-1 produced significant weight reduction without a statistically significant

decrease in food consumption,” said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals. “The contrasting

observations in lean-mass outcomes and weight regain following treatment discontinuation compared with the semaglutide reference group

are also scientifically interesting. Together, these findings raise the possibility that SKNY-1 may influence how the body utilizes energy,

potentially offering a differentiated metabolic approach to weight management. These results further expand and confirm previous studies,

which have demonstrated increased energy expenditure without changes in food intake.”

“Our

next study will investigate this hypothesis more directly through measurements of energy expenditure and other metabolic parameters,

while further characterizing SKNY-1’s effects on body composition and weight regulation.”

Continued

Development of SKNY-1

MIRA

is advancing SKNY-1 through longer-term preclinical studies to further assess weight reduction, body composition and metabolic effects,

while continuing its IND-enabling development activities and chemistry, manufacturing and controls (CMC) manufacturing efforts to support

future clinical development.

About

SKNY-1

is MIRA Pharmaceuticals’ investigational oral drug candidate being developed for obesity and metabolic disorders. The compound

is a cannabinoid analog being investigated for its potential effects on biological pathways involved in metabolic regulation.

Previously

published preclinical research in a zebrafish model of obesity demonstrated approximately 30% weight reduction, accompanied by maintenance

of whole-body density, reductions in hepatic triglyceride accumulation, and changes in appetite-related signaling.

The

latest pilot study in diet-induced obese mice expands this exploratory research into a mammalian obesity model, providing additional

evidence of SKNY-1’s potential as an oral therapeutic candidate for obesity.

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 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 http://www.mirapharmaceuticals.com/.

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

Investor

and Media Contact

Krystina

Quintana

MIRA

Pharmaceuticals

info@mirapharma.com

(786)

432-9792

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