Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-028992

Filed: 2026-06-17

Period: 2026-06-17

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): June 17, 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.

June 17, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing the submission of a Phase 2a

clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company’s proprietary oral NMDA receptor

modulator, in chemotherapy-induced peripheral neuropathy (CIPN). A copy of the press release is attached hereto as Exhibit 99.1 and incorporated

herein by reference.

connection with the submission, the Company received an acknowledgment of receipt from the FDA confirming acceptance of the Phase 2a

clinical trial protocol submission for Protocol Mira-002. A copy of the FDA submission receipt is attached hereto as Exhibit 99.2 and

incorporated herein by reference.

The

information in this Item 7.01, including Exhibit 99.1 and Exhibit 99.2, 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.

Item

9.01 Financial Statements and Other Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release of MIRA Pharmaceuticals, Inc., dated June 17, 2026

99.2

FDA Acknowledgment of Receipt — Phase 2a Clinical Trial Protocol Submission, Protocol Mira-002

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:

June 17, 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 Submits Phase 2a Clinical Trial Protocol to FDA for Ketamir-2 in Chemotherapy-Induced Peripheral Neuropathy

Randomized,

double-blind, placebo-controlled study to evaluate safety, tolerability, and dose-response efficacy of oral Ketamir-2 at a leading U.S.

cancer center

MIAMI,

FL / ACCESS Newswire / June 17, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),

a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today

announced the submission of a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) for Ketamir-2, the Company’s

proprietary oral NMDA receptor modulator, in chemotherapy-induced peripheral neuropathy (CIPN).

Addressing

a Significant Unmet Medical Need

Chemotherapy-induced

peripheral neuropathy is one of the most common and debilitating consequences of cancer treatment. It affects an estimated 30 to 40 percent

of patients who receive neurotoxic chemotherapy, and approximately 3 million new persistent cases are estimated annually worldwide. For

many patients, symptoms including pain, numbness, tingling, and loss of sensation do not resolve when treatment ends. Roughly 30 percent

continue to experience them six months or more after completing chemotherapy, often with lasting impact on their ability to function

and their overall quality of life.

Despite

how common and disabling the condition is, there are currently no FDA-approved therapies specifically for CIPN. Oncologists rely on medications

such as gabapentin, pregabalin, duloxetine, and tricyclic antidepressants, none of which were developed for this purpose, and many of

which provide incomplete relief. In severe cases, CIPN forces dose reductions or the discontinuation of chemotherapy entirely, potentially

compromising cancer outcomes. The absence of an approved treatment has remained one of the more glaring gaps in oncology supportive care.

About

the Phase 2a Study (Protocol Mira-002)

The

planned Phase 2a study is a randomized, double-blind, placebo-controlled, three-period crossover trial that will evaluate the safety,

tolerability, and dose-response relationship of oral Ketamir-2 in patients with moderate-to-severe persistent CIPN. The study will be

conducted at a leading U.S. cancer center.

Patients

will be enrolled and randomized to receive Ketamir-2 at one of two dose levels, 300 mg or 600 mg, or a matching placebo, across three

sequential seven-day treatment periods, each separated by a two-week washout. Because each patient moves through all three treatment

sequences, the crossover design allows each participant to serve as their own control, producing a more reliable signal with a smaller

study population.

The

primary objectives are to characterize the safety and tolerability of Ketamir-2 at both dose levels and to evaluate its dose-response

relationship on neuropathic pain intensity, measured by change from baseline in the weekly mean 11-point Numeric Rating Scale pain score.

Secondary objectives include the proportion of patients achieving meaningful pain reductions of 30 percent or more and 50 percent or

more, changes in CIPN-related symptoms and functional status measured by the EORTC QLQ-CIPN20, and assessment of central nervous system

pharmacodynamic effects. Each participant will be in the study for up to 82 days.

be eligible, patients must have experienced persistent CIPN for at least three months following chemotherapy, report a baseline pain

score of 4 or higher on the NRS scale, and have underlying cancer that is clinically stable with no active disease requiring systemic

treatment at study entry.

The

submission builds on results from the successfully completed MIRA-001 Phase 1 study, which enrolled 56 healthy volunteers across single

and multiple ascending dose cohorts. No serious adverse events or dose-limiting toxicities were observed at any dose tested, and the

pharmacokinetic profile supported the dose levels and once-daily administration schedule selected for Phase 2a.

Management

Commentary

“CIPN

has been overlooked for too long,” said Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals. “Millions

of cancer survivors are managing real, ongoing pain with medications that were never approved for this condition and that often do not

work well enough. Ketamir-2 came out of Phase 1 with a clean safety record, and this Phase 2a study is the next step toward building

the evidence base the program needs.”

Dr.

Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals, commented: “The crossover design we selected for this study

is scientifically well-suited to this patient population. Having each participant experience all three treatment periods gives us a more

precise read on dose-response while keeping the study size manageable. The Phase 1 data gave us clear guidance on dosing, and Phase 2a

is designed to answer the questions that matter most going forward — how Ketamir-2 performs on safety and pain relief in patients

who need it.”

About

Ketamir-2

is an oral NMDA receptor modulator in development for chronic neuropathic pain. The NMDA receptor pathway is well established in neuropathic

pain biology, and ketamine has long demonstrated activity there, but its use for chronic conditions has been constrained by the need

for intravenous administration, significant dissociative side effects, Schedule III controlled substance status, and the clinical infrastructure

required to administer and monitor it. Ketamir-2 was built to capture the mechanism without those limitations, delivered orally, dosed

once daily, and confirmed by the DEA as non-scheduled. MIRA holds exclusive worldwide rights to Ketamir-2 with intellectual property

secured across 10 major markets, including the United States, European Union, China, Japan, Canada, Australia, India, Israel, Mexico,

and South Korea.

Ketamir-2

has not been approved by the U.S. Food and Drug Administration for any indication. Its safety and efficacy have not been established.

About

MIRA Pharmaceuticals, Inc.

MIRA

Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational

therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company’s pipeline includes oral drug candidates being

evaluated for neuropathic pain, inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive impairment. For more

information, please visit www.mirapharmaceuticals.com.

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 Ketamir-2;

the planned Phase 2a clinical trial, including its design, objectives, enrollment, timing, initiation and potential outcomes; the potential

efficacy, safety, tolerability and therapeutic benefits of Ketamir-2; the potential advantages of Ketamir-2 compared to existing treatment

options; the potential market opportunity for Ketamir-2; future regulatory interactions; intellectual property protection; strategic

partnership opportunities; and the future development and commercialization of Ketamir-2. These 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. You are encouraged to

read our filings with the SEC, available at the SEC website and in the “Investors” section of our website at MIRA Investors,

for a discussion of these and other risks and uncertainties.

Contact:

Krystina

Quintana

info@mirapharma.com

(786)

432-9792

EX-99.2

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