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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): July 10, 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
July 10, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from preclinical
studies evaluating optimized oral formulations of MIRA-55, the Company’s oral drug candidate being developed as a non-opioid therapy
for chronic inflammatory pain.
Following
evaluation of multiple oral formulations, the Company selected a lead formulation demonstrating favorable oral bioavailability together
with sustained systemic exposure and reproducible distribution into both brain and liver tissue following oral administration. The study
included an intravenous reference arm to characterize absolute oral bioavailability and support selection of the lead formulation based
on its overall pharmacokinetic profile.
The
Company believes these pharmacokinetic findings further strengthen the development profile of MIRA-55 by demonstrating that the optimized
oral formulation provides meaningful systemic exposure together with distribution into pharmacologically relevant tissues related to
both central and peripheral mechanisms of chronic inflammatory pain. These findings build upon the Company’s previously reported
preclinical studies demonstrating that oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model,
outperforming injected morphine, while also exhibiting a differentiated pharmacological profile relative to THC. In separate mechanistic
and behavioral studies, MIRA-55 demonstrated anxiolytic activity, did not produce the characteristic central nervous system effects associated
with THC, and was shown to interact with the cannabinoid system through a mechanism distinct from THC.
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.
Item
9.01 Financial Statements and Other Exhibits.
(d)
Exhibits.
| Exhibit
No. |
|
Description |
| 99.1 |
|
Press Release of MIRA Pharmaceuticals, Inc., dated July 10, 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:
July 10, 2026 |
By: |
/s/
Erez Aminov |
| |
Name: |
Erez
Aminov |
| |
Title: |
Chief
Executive Officer |
Exhibit 99.1
MIRA
Pharmaceuticals Reports Successful Formulation Results Supporting Development of MIRA-55 as a Non-Opioid Oral Therapy for Chronic Inflammatory
Pain
Optimized
Oral Formulation Demonstrates Favorable Oral Bioavailability Together with Robust Brain and Liver Distribution Following Oral Administration
MIAMI,
FL / ACCESS Newswire / July 10, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”),
a clinical-stage pharmaceutical company, today announced positive results from preclinical studies evaluating optimized oral formulations
of MIRA-55, the Company’s oral drug candidate being developed as a non-opioid therapy for chronic inflammatory pain.
Following
evaluation of multiple oral formulations, the Company selected a lead formulation demonstrating favorable oral bioavailability together
with sustained systemic exposure and reproducible distribution into both brain and liver tissue following oral administration. Collectively,
these findings support the continued development of MIRA-55 as an orally administered therapy for chronic inflammatory pain.
“Patients
deserve safer and more effective non-opioid treatment options for chronic inflammatory pain,” said Erez Aminov, Chief Executive
Officer of MIRA Pharmaceuticals. “These formulation and pharmacokinetic findings represent another important step in advancing
MIRA-55 as a differentiated oral therapy designed to address that need.”
The
objective of the study was to optimize the oral formulation of MIRA-55 by comparing multiple formulations in a preclinical pharmacokinetic
study. An intravenous reference arm was included to characterize absolute oral bioavailability and support selection of the lead formulation
based on its overall pharmacokinetic profile.
The
selected formulation demonstrated reproducible distribution into both brain and liver tissue following oral administration. Brain exposure
may support modulation of central pain-processing pathways, while peripheral distribution may contribute to the anti-inflammatory activity
previously observed in MIRA’s preclinical efficacy studies. Together, these findings demonstrate that the optimized formulation
successfully delivers MIRA-55 to pharmacologically relevant tissues associated with both central and peripheral mechanisms of chronic
inflammatory pain.
“Formulation
optimization is far more than a pharmaceutical exercise—it is what enables a molecule to consistently engage its intended biological
targets,” said Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA Pharmaceuticals. “The combination of favorable
oral exposure together with reproducible brain and peripheral tissue distribution provides important support for MIRA-55’s proposed
mechanism of action and its continued development as an oral therapy for chronic inflammatory pain.”
Today’s
pharmacokinetic findings build upon MIRA’s previously reported preclinical studies demonstrating that oral MIRA-55 normalized pain
and reduced inflammation in a validated inflammatory pain model, outperforming injected morphine, while also exhibiting a differentiated
pharmacological profile relative to THC. In separate mechanistic and behavioral studies, MIRA-55 demonstrated anxiolytic activity, did
not produce the characteristic central nervous system effects associated with THC, and was shown to interact with the cannabinoid system
through a mechanism distinct from THC. Collectively, these efficacy, behavioral, mechanistic, and pharmacokinetic findings continue to
strengthen the overall development package supporting MIRA-55 as a differentiated oral therapeutic candidate for chronic inflammatory
pain.
The
Company plans to continue evaluating the relationship between tissue exposure, pharmacodynamic activity, and therapeutic efficacy as
MIRA-55 advances through additional preclinical development.
About
Mira-55
Mira-55
is a next-generation cannabinoid analog designed to modulate cannabinoid receptor activity, including CB1 and CB2 pathways, while minimizing
CB1-related psychoactivity. Following scientific review, the U.S. Drug Enforcement Administration (DEA) 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 for
neurologic, inflammatory, metabolic, and neuropsychiatric disorders. The Company’s pipeline includes Ketamir-2, an investigational
oral therapy that successfully completed a Phase 1 clinical trial and for which the Company has submitted a Phase 2a protocol to the
U.S. Food and Drug Administration (FDA) under its active U.S. Investigational New Drug (IND) application for chemotherapy-induced peripheral
neuropathy (CIPN); MIRA-55, a preclinical oral drug candidate being developed for chronic inflammatory pain; and SKNY-1,
a preclinical oral drug candidate being developed for obesity and addiction-related disorders.
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 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 SKNY-1;
its potential efficacy, safety, tolerability, pharmacokinetic profile, tissue distribution, mechanism of action, and therapeutic benefits;
the potential advantages of SKNY-1 compared to existing treatment options; the potential for once-daily oral dosing; the preservation
of lean body mass; future preclinical studies; future clinical development; regulatory interactions; intellectual property protection;
strategic partnership opportunities; and the future development and commercialization of SKNY-1. 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.
We
caution investors not to place undue reliance on the forward-looking statements contained in this press release. Investors are encouraged
to review the Company’s filings with the SEC, available at www.sec.gov, and in the Investors section of the Company’s
website at www.mirapharma.com, for a discussion of these and other risks and uncertainties.
Contact
Krystina Quintana
MIRA Pharmaceuticals, Inc.
info@mirapharma.com
(786) 432-9792
