Form 8-K

8-K — MIRA PHARMACEUTICALS, INC.

Accession: 0001493152-26-043051

Filed: 2026-09-17

Period: 2026-09-17

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): September 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.

September 17, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that its Phase 2a clinical

program evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (“CIPN”) has advanced toward site initiation following

review of the study protocol by the U.S. Food and Drug Administration (“FDA”). Following FDA review and comments, the Company

incorporated the FDA’s feedback into the Phase 2a protocol, which has been submitted for Institutional Review Board review at a

leading cancer research institution.

copy of the press release 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 (the “Exchange Act”), or otherwise subject to the liabilities

of that section, nor shall such information 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 September 17, 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 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 Advances Ketamir-2 to Phase 2a in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Following FDA Review

Protocol

Submitted for IRB Review at a Leading Cancer Research Institution, Advancing the Study Toward Site Initiation

MIAMI,

Sept. 17, 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 that, following review

and comments from the U.S. Food and Drug Administration (FDA), the Phase 2a protocol evaluating Ketamir-2 in chemotherapy-induced peripheral

neuropathy (CIPN) has been submitted for Institutional Review Board (IRB) review at a leading cancer research institution.

MIRA

incorporated the FDA’s feedback into the protocol and is targeting site initiation in the first quarter of 2027, subject to completion

of IRB review and other routine site activation requirements. The study represents Ketamir-2’s first clinical evaluation in patients

with CIPN and is designed to generate initial efficacy and dose-response data while further characterizing safety and tolerability.

“We

are entering an important stage for Ketamir-2 as we prepare to evaluate the drug for the first time in patients with persistent CIPN,”

said Erez Aminov, CEO of MIRA. “This marks the transition from establishing safety and pharmacokinetics in healthy volunteers

to evaluating Ketamir-2’s potential therapeutic effect in patients.”

About

the Phase 2a Study

The

randomized, double-blind, placebo-controlled, three-period crossover study will enroll adults with moderate-to-severe persistent CIPN.

Participants will receive Ketamir-2 at 300 mg and 600 mg, as well as placebo, in a defined treatment sequence across three seven-day

treatment periods separated by 13-day washout periods, allowing each participant to serve as their own control.

The

study will evaluate the safety, tolerability, efficacy, and dose-response relationship of oral Ketamir-2, including its effect on post-chemotherapy

neuropathic pain intensity. Additional assessments will evaluate CIPN-related symptoms and functional status, as well as potential central

nervous system adverse effects.

The

study builds on MIRA’s completed Phase 1 clinical program in healthy volunteers, in which Ketamir-2 demonstrated a favorable safety,

tolerability, and pharmacokinetic profile, with no serious adverse events or dose-limiting toxicities reported. The Phase 2a study will

be conducted under MIRA’s active Investigational New Drug (IND) application.

Addressing

a Significant Unmet Need in Neuropathic Pain

CIPN

is a painful and potentially persistent complication of certain commonly used chemotherapies that can continue long after cancer treatment

has ended. Treatment options remain limited, and there are currently no FDA-approved therapies specifically indicated for CIPN. Existing

treatment approaches offer limited options for managing painful CIPN, underscoring the need for new therapies specifically developed

for this condition.

Ketamine

has demonstrated analgesic activity in neuropathic pain through modulation of the NMDA receptor pathway, supporting the therapeutic relevance

of this mechanism. However, its broader use as a chronic treatment can be constrained by intravenous administration, dissociative and

other neuropsychiatric effects, monitoring requirements, and its Schedule III controlled-substance status.

Ketamir-2

is being developed as an oral NMDA receptor modulator designed to engage this therapeutically relevant pathway while potentially overcoming

key limitations associated with ketamine. Ketamir-2 is orally administered; its Phase 1 pharmacokinetic profile supports once-daily dosing,

and it is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

“There

is a strong scientific rationale for targeting NMDA receptor signaling in neuropathic pain,” said Itzchak Angel, Ph.D., Chief

Scientific Advisor of MIRA. “Ketamine has provided important clinical validation of this pathway, but its properties can limit

its practicality for chronic use. Ketamir-2 was designed as an oral NMDA receptor modulator with high selectivity and a differentiated

pharmacologic profile, and we believe this Phase 2a study will provide an important first opportunity to determine whether this profile

can translate into meaningful pain reduction in patients with persistent CIPN.”

While

CIPN is the initial patient population being evaluated in Phase 2a, MIRA believes that positive clinical evidence in CIPN could support

the evaluation of Ketamir-2 across additional neuropathic pain conditions where NMDA receptor signaling may play a role. The Company

views CIPN as a potential clinical entry point into the broader neuropathic pain market.

October

Scientific Presentation and BioJapan Participation

MIRA

expects to present Ketamir-2 at the International Conference on Addiction and Psychiatry in Tokyo, Japan, on October 5–6, 2026,

where an abstract titled “An Oral Selective NMDA Modulator for Chemotherapy-Induced Peripheral Neuropathy—Phase 1 Safety,

Pharmacokinetics, and Clinical Development Update” has been accepted for oral presentation by Dr. Itzchak Angel, MIRA’s

Chief Scientific Advisor.

MIRA

also expects to participate in BioJapan in October as the Company continues licensing and strategic partnership discussions around

Ketamir-2 and its broader pipeline.

About

Ketamir-2

is MIRA Pharmaceuticals’ proprietary oral NMDA receptor modulator in clinical development for neuropathic pain. The compound is

designed to selectively modulate the NMDA receptor PCP binding site with low binding affinity and limited off-target receptor activity.

MIRA

holds exclusive worldwide rights to Ketamir-2 and is pursuing intellectual property protection across major global pharmaceutical markets.

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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