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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 |
| 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 ☒
If
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.
On
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.
A
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 |
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
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.
Previous
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
