Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-048022

Filed: 2026-10-22

Period: 2026-10-22

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 22, 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.

October 22, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from a 21-day IND-enabling

preclinical proof-of-concept study evaluating MIRA-55 in a validated model of chronic inflammatory pain.

The

study demonstrated that once-daily oral MIRA-55 significantly reduced mechanical and thermal pain hypersensitivity compared with vehicle-treated

animals (p < 0.001). MIRA-55 achieved pain-relieving effects comparable in magnitude to celecoxib (Celebrex®), a widely prescribed

medication for pain and inflammation. The effects were sustained throughout the study without evidence of tolerance or adverse clinical

signs.

MIRA-55

also reduced inflammation-associated paw swelling to a similar magnitude as celecoxib and demonstrated consistent pain-relieving activity

in both male and female animals.

These

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

and reduced inflammation in an acute inflammatory pain model, outperforming injected morphine in that study. The Company believes the

results further strengthen MIRA-55’s preclinical development profile and support its continued advancement toward a planned Investigational

New Drug (IND) submission in the first quarter of 2027.

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.

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 22, 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 22, 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 MIRA-55 Demonstrated Significant Pain Relief Comparable to Celebrex in Chronic Inflammatory Pain Study

Positive

IND-Enabling Proof-of-Concept Study Demonstrates Sustained Efficacy Without Observed Tolerance, Reduced Inflammation-Associated Swelling,

and Favorable Tolerability

MIAMI,

Oct. 22 (GLOBE NEWSWIRE) — MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),

a clinical-stage pharmaceutical company developing novel oral therapies for neurologic, inflammatory and metabolic disorders, today announced

positive results from a 21-day preclinical proof-of-concept study evaluating oral MIRA-55 in a validated model of chronic inflammatory

pain. The results support the continued advancement of MIRA-55 toward an Investigational New Drug (IND) submission.

The

study demonstrated that once-daily oral MIRA-55 significantly reduced both mechanical and thermal pain hypersensitivity (p < 0.001

versus vehicle) as from the lowest dose used. MIRA-55 achieved pain-relieving effects comparable in magnitude to celecoxib (Celebrex®),

a widely prescribed medication for pain and inflammation, at the higher doses evaluated.

Importantly,

the effects were maintained throughout the three-week study without evidence of tolerance. MIRA-55 also reduced inflammation-associated

swelling and was well tolerated, with no adverse clinical signs observed during repeated daily administration.

These

findings build on MIRA’s earlier preclinical studies, including previously reported results demonstrating that oral MIRA-55 normalized

pain responses and reduced inflammation in an acute inflammatory pain model, outperforming injected morphine in that study. Together,

these findings extend MIRA-55’s demonstrated preclinical analgesic activity into a model of persistent, chronic inflammatory pain,

further supporting its development as a next-generation oral therapy designed to provide effective, long-term pain relief with an improved

safety and tolerability profile.

Key

Study Highlights

● Significant

Pain Relief: MIRA-55 significantly reduced both mechanical and thermal pain hypersensitivity

compared with vehicle-treated animals (p < 0.001).

● Comparable

to Celebrex: MIRA-55 demonstrated pain-relieving effects comparable in magnitude to celecoxib,

with no statistically significant differences observed between those treatments.

● Sustained

Efficacy Without Observed Tolerance: Pain relief was maintained throughout the three-week

study, with no observed decline in effectiveness during repeated daily dosing.

● Reduced

Inflammation-Associated Swelling: MIRA-55 reduced paw swelling to a similar magnitude

as the reduction observed with celecoxib.

● Consistent

Results Across Both Sexes: MIRA-55 demonstrated comparable pain-relieving activity in

male and female animals.

● Favorable

Observed Tolerability: No adverse clinical signs or deaths were reported, and normal

body-weight gain was maintained throughout the treatment period.

Advancing

a Potential New Treatment for Chronic Inflammatory Pain

Chronic

inflammatory pain remains a significant medical challenge, affecting patients with conditions such as arthritis and other inflammatory

disorders. Existing treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs), can provide meaningful relief but may be limited

by gastrointestinal, cardiovascular, renal, and other safety considerations, particularly with prolonged use.

MIRA-55

is a next-generation oral synthetic cannabinoid analog designed to modulate cannabinoid receptor pathways involved in pain signaling

and inflammation. The program aims to deliver effective, sustained pain relief while minimizing unwanted effects associated with existing

treatment approaches.

The

U.S. Drug Enforcement Administration has determined that MIRA-55 is not a controlled substance.

“We

are building a differentiated pain therapeutics franchise around two distinct programs addressing major unmet medical needs,” said

Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals. “With Ketamir-2 advancing toward Phase 2 clinical

development for neuropathic pain and MIRA-55 progressing toward an IND for inflammatory pain, we are creating a pipeline of oral therapies

targeting distinct but complementary areas of pain. We believe this strategy positions MIRA to create meaningful value for patients and

shareholders as both programs advance through development.”

Study

Design and Scientific Findings

The

21-day study was conducted by an independent contract research organization using the Complete Freund’s Adjuvant (CFA) model, a

well-established preclinical model used to investigate persistent inflammatory pain.

The

study included 72 male and female rats. MIRA-55 was administered orally once daily at multiple dose levels and evaluated against a vehicle

control and celecoxib, an established prescription anti-inflammatory medication.

Researchers

assessed mechanical and thermal pain sensitivity, inflammation-associated paw swelling, and general tolerability throughout the study.

MIRA-55

demonstrated statistically significant pain-relieving activity across all tested doses, with a dose-related response. Analgesic activity

was observed following the first administration at the highest dose, while sustained effects were established within the first several

days of treatment and maintained through the end of the study.

“One

of the most encouraging aspects of these findings is the durability of the response,” said Itzchak Angel, Ph.D., Chief Scientific

Advisor of MIRA Pharmaceuticals. “MIRA-55 demonstrated sustained analgesic activity over repeated low oral daily dosing, without

evidence of tolerance, and produced consistent effects in both male and female animals. These results extend our earlier acute pain findings

into a model of persistent inflammatory pain. The relationship between pain relief and reduced swelling also suggests potentially distinct

contributions from pain-signaling and inflammatory pathways, which we are continuing to investigate.”

Supporting

Advancement Toward Clinical Development

The

positive findings provide additional proof-of-concept evidence supporting MIRA-55’s ongoing IND-enabling development program.

Additional

tissue analyses are underway to evaluate inflammatory cytokines and molecular markers associated with pain signaling and neuroinflammation,

including changes in the dorsal root ganglia and spinal cord. These analyses are expected to provide further insight into MIRA-55’s

mechanism of action and help inform its continued development.

MIRA

is advancing MIRA-55 toward a planned IND submission in the first quarter of 2027, subject to completion of the remaining required preclinical

and regulatory activities.

About

MIRA-55

is an orally administered, next-generation synthetic cannabinoid analog being developed as a potential treatment for inflammatory pain.

The compound is designed to modulate cannabinoid receptor pathways involved in pain and inflammation while minimizing unwanted psychoactive

effects.

preclinical studies have demonstrated analgesic and anti-inflammatory activity, including pain normalization in comparison with morphine

in an acute inflammatory pain model. More recent findings demonstrate sustained pain-relieving activity in a model of chronic inflammatory

pain.

The

U.S. Drug Enforcement Administration has determined that MIRA-55 is not a controlled substance. MIRA-55 remains in preclinical development,

and its safety and efficacy in humans have not been established.

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.

Investor

and Media Contact

Krystina

Quintana

MIRA Pharmaceuticals

info@mirapharma.com

(786) 432-9792

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