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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 28, 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.
MIRA
Pharmaceuticals Reports Significant Weight and Fat Reduction With Oral SKNY-1 in Obese Mice, Showing Favorable Lean-Mass and Weight-Regain
Outcomes Compared With Semaglutide
On
October 28, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) announced initial positive proof-of-concept results from an
exploratory pilot study evaluating SKNY-1, its investigational oral drug candidate for obesity and metabolic disorders.
Conducted
in an established diet-induced obesity (DIO) mouse model, the study demonstrated statistically significant reductions in body weight
and fat mass following oral administration of SKNY-1 compared with vehicle-treated controls. The study also identified three potentially
meaningful areas of differentiation from the semaglutide reference group:
| 1. | Food
Intake: Weight reduction occurred without a statistically significant decrease in food
consumption, raising the possibility that SKNY-1 may influence metabolic pathways beyond
appetite suppression. Following treatment discontinuation, oral SKNY-1-treated groups showed
no statistically significant increase in food consumption relative to vehicle controls, while
semaglutide-treated mice demonstrated a statistically significant increase. |
| 2. | Lean-Mass
Outcomes: Oral SKNY-1-treated mice did not demonstrate statistically significant lean-mass
loss relative to vehicle controls, while semaglutide-treated mice demonstrated statistically
significant lean-mass loss compared with vehicle-treated controls. |
| 3. | Weight
Regain Following Treatment Discontinuation: Oral SKNY-1-treated mice demonstrated slow
and limited weight regain during the two-week observation period following treatment cessation,
contrasting with rapid and substantial weight rebound in semaglutide-treated mice. |
A
copy of the Company’s press release, scheduled for distribution on October
29, 2026, 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, 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 Securities Exchange Act of
1934, as amended, 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 29, 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 28, 2026 |
By: |
/s/
Erez Aminov |
| |
Name: |
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
Exhibit 99.1
MIRA
Pharmaceuticals Reports Significant Weight and Fat Reduction With Oral SKNY-1 in Obese Mice, Showing Favorable Lean-Mass and Weight-Regain
Outcomes Compared With Semaglutide
SKNY-1’s
Weight Reduction Without Significant Changes in Food Consumption Suggests a Potential Role for Energy Expenditure, Contrasting With Semaglutide’s
Initial Food-Intake Suppression and Significant Post-Treatment Increase
MIAMI,
Oct. 29, 2026 (GLOBE NEWSWIRE) — MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),
a clinical-stage pharmaceutical company developing novel oral therapeutics, today announced initial positive proof-of-concept results
from an exploratory pilot study evaluating SKNY-1, its investigational oral drug candidate for obesity and metabolic disorders.
Conducted
in an established diet-induced obesity (DIO) mouse model, the study demonstrated statistically significant reductions in body weight
and fat mass following oral administration of SKNY-1 compared with vehicle-treated controls.
Importantly,
weight reduction occurred without a statistically significant decrease in food consumption, raising the possibility that SKNY-1 may influence
metabolic pathways beyond appetite suppression.
The
study also identified three potentially meaningful areas of differentiation from the semaglutide reference group: effects on food intake,
lean-mass outcomes, and weight regain following treatment discontinuation. Together, these findings expand upon previous SKNY-1 research
and support its continued development as a potentially differentiated oral approach to weight management.
“Obesity
represents one of the largest and fastest-growing opportunities in healthcare, with the potential for multiple multibillion-dollar therapies,”
said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. “We believe the future of obesity treatment will extend
beyond a single class of drugs. Patients have different needs, and there is tremendous opportunity for innovative therapies that work
through distinct mechanisms and offer favorable profiles for long-term weight management. What makes SKNY-1 particularly exciting is
that our findings point toward a potentially differentiated metabolic approach, with encouraging signals regarding body composition and
weight maintenance following treatment discontinuation. We believe these characteristics could become important advantages as we continue
advancing SKNY-1, positioning it as a potentially valuable asset within our pipeline and an opportunity to participate in this significant
global market.”
Key
Findings From the SKNY-1 Pilot Study
Statistically
Significant Weight and Fat Reduction
Oral
SKNY-1 demonstrated statistically significant reductions in body weight and fat mass compared with vehicle-treated controls. The majority
of the treatment-associated weight difference was attributable to fat reduction, providing encouraging evidence of SKNY-1’s activity
in an established obesity model.
Favorable
Lean-Mass Findings Compared With the Semaglutide Reference Group
At
the Day 14 body-composition assessment, oral SKNY-1-treated mice did not demonstrate statistically significant lean-mass loss relative
to vehicle controls.
In
contrast, semaglutide-treated mice demonstrated statistically significant lean-mass loss compared with vehicle-treated controls.
Limited
Weight Regain Following Treatment Discontinuation Compared With Semaglutide
During
the two-week observation period following treatment cessation, oral SKNY-1-treated mice demonstrated slow and limited weight regain.
In
contrast, semaglutide-treated mice experienced rapid and substantial weight rebound, which was accompanied by a statistically significant
increase in food consumption relative to vehicle controls, while oral SKNY-1-treated groups showed no statistically significant increase
in food consumption.
Investigating
a Potentially Differentiated Metabolic Mechanism
The
study’s findings raise the possibility that SKNY-1 may influence energy expenditure, energy utilization, or other metabolic pathways
involved in weight regulation, rather than relying primarily on appetite suppression.
These
observations provide a scientific rationale for investigating SKNY-1’s potentially differentiated metabolic mechanism.
“One
of the most intriguing findings from this pilot study is that SKNY-1 produced significant weight reduction without a statistically significant
decrease in food consumption,” said Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals. “The contrasting
observations in lean-mass outcomes and weight regain following treatment discontinuation compared with the semaglutide reference group
are also scientifically interesting. Together, these findings raise the possibility that SKNY-1 may influence how the body utilizes energy,
potentially offering a differentiated metabolic approach to weight management. These results further expand and confirm previous studies,
which have demonstrated increased energy expenditure without changes in food intake.”
“Our
next study will investigate this hypothesis more directly through measurements of energy expenditure and other metabolic parameters,
while further characterizing SKNY-1’s effects on body composition and weight regulation.”
Continued
Development of SKNY-1
MIRA
is advancing SKNY-1 through longer-term preclinical studies to further assess weight reduction, body composition and metabolic effects,
while continuing its IND-enabling development activities and chemistry, manufacturing and controls (CMC) manufacturing efforts to support
future clinical development.
About
SKNY-1
SKNY-1
is MIRA Pharmaceuticals’ investigational oral drug candidate being developed for obesity and metabolic disorders. The compound
is a cannabinoid analog being investigated for its potential effects on biological pathways involved in metabolic regulation.
Previously
published preclinical research in a zebrafish model of obesity demonstrated approximately 30% weight reduction, accompanied by maintenance
of whole-body density, reductions in hepatic triglyceride accumulation, and changes in appetite-related signaling.
The
latest pilot study in diet-induced obese mice expands this exploratory research into a mammalian obesity model, providing additional
evidence of SKNY-1’s potential as an oral therapeutic candidate for obesity.
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 http://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
