Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-040930

Filed: 2026-09-01

Period: 2026-09-01

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): September 1, 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

of 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.

September 1, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from completed

7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55, the Company’s investigational oral, non-opioid drug candidate

being developed for inflammatory pain.

The

results are expected to inform dose selection for the next phase of the Company’s ongoing IND-enabling program. Subject to successful

completion of the remaining IND-enabling studies, applicable regulatory requirements and other development considerations, the Company

is targeting submission of an Investigational New Drug application for MIRA-55 to the U.S. Food and Drug Administration in the first

quarter of 2027.

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 September 1, 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: September 1, 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 Advances Non-Opioid Oral MIRA-55 for Inflammatory Pain Toward IND

Positive

Toxicology Results From 7-Day Rat and Dog Studies Characterize Tolerability and Inform Dose Selection for Next Phase of IND-Enabling

Program, Targeting Q1 2027 IND Submission

MIAMI,

Sept. 1, 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 results from completed 7-day dose-range

finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs. MIRA-55 is the Company’s investigational oral, non-opioid drug

candidate being developed for inflammatory pain.

Cross-Species

Study Findings

The

completed studies characterized tolerability, toxicity, and systemic exposure across both species. Rats were identified as the more sensitive

species, while dogs demonstrated greater tolerance across the dose levels studied. Toxicokinetic analyses confirmed systemic exposure

in both species and characterized how exposure changed with dose and repeated administration.

Importantly,

the studies achieved their intended dose-range finding objective by generating the cross-species information needed to guide dose selection

for the next phase of MIRA-55’s ongoing IND-enabling program. The Company plans to use these findings to inform the design of subsequent

GLP-compliant toxicology studies.

“Inflammatory

pain is a massive unmet need affecting millions of patients globally, and current treatments carry significant liabilities that drive

patients to seek alternatives. MIRA-55 represents a genuine opportunity to address that need with a differentiated approach. These tox

results are an important milestone as we move toward human studies,” said Erez Aminov, CEO of MIRA.

“MIRA-55

was designed to provide a differentiated approach to inflammatory pain by modulating cannabinoid pathways involved in both pain signaling

and inflammation,” said Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA. “The results of these studies further characterize

the compound’s tolerability and systemic exposure across species and add to a broader preclinical profile that has demonstrated

analgesic and anti-inflammatory activity, while prior behavioral studies showed that MIRA-55 did not produce the characteristic CNS effects

associated with THC. Taken together, these findings strengthen the scientific foundation for continued IND-enabling development.”

Significant Need for New Non-Opioid Pain Treatments

The

need for new approaches to pain management remains substantial. In 2023, 24.3% of U.S. adults experienced chronic pain, including 8.5%

who experienced high-impact chronic pain that frequently limited life or work activities, according to the U.S. Centers for Disease Control

and Prevention.

The

global non-opioid pain-treatment market was valued at approximately $45.3 billion in 2024 and is projected to reach approximately $70.3

billion by 2030, representing a projected compound annual growth rate of approximately 7.7%, according to Grand View Research.

MIRA-55

is being developed within this landscape as an investigational oral, non-opioid therapy for inflammatory pain. In previously reported

preclinical studies conducted separately from the toxicology studies announced today, oral MIRA-55 normalized pain responses and significantly

reduced inflammation in a validated inflammatory pain model, outperforming injected morphine in pain normalization.

MIRA

believes this combination of analgesic and anti-inflammatory activity represents a differentiated approach to inflammatory pain, where

the goal is not only to address pain signaling but also the inflammatory processes contributing to pain.

Steps

MIRA

plans to use the completed dose-range finding data to support the next phase of its ongoing IND-enabling toxicology program.

parallel, the Company has successfully advanced manufacturing scale-up and formulation work for MIRA-55 in support of its broader preparations

for clinical development.

Subject

to successful completion of the remaining IND-enabling studies, applicable regulatory requirements and other development considerations,

the Company is targeting submission of an Investigational New Drug application for MIRA-55 to the U.S. Food and Drug Administration in

the first quarter of 2027.

About

MIRA-55

is an investigational oral small-molecule drug candidate being developed as a potential non-opioid therapy for inflammatory pain. The

compound is designed to modulate cannabinoid receptor pathways associated with pain and inflammation while minimizing the characteristic

psychoactive effects associated with THC.

previously reported preclinical studies, oral MIRA-55 demonstrated analgesic and anti-inflammatory activity, including normalization

of pain responses and reductions in inflammation in a validated inflammatory pain model. Additional behavioral and mechanistic studies

showed that MIRA-55 did not produce the characteristic CNS effects associated with THC and demonstrated a differentiated pharmacological

profile.

Following

scientific review, the U.S. Drug Enforcement Administration 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. 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 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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