false
0001904286
0001904286
2026-09-01
2026-09-01
iso4217:USD
xbrli:shares
iso4217:USD
xbrli:shares
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 1, 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
September 1, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from completed
7-day dose-range finding toxicology and toxicokinetic studies of MIRA-55, the Company’s investigational oral, non-opioid drug candidate
being developed for inflammatory pain.
The
results are expected to inform dose selection for the next phase of the Company’s ongoing IND-enabling program. Subject to successful
completion of the remaining IND-enabling studies, applicable regulatory requirements and other development considerations, the Company
is targeting submission of an Investigational New Drug application for MIRA-55 to the U.S. Food and Drug Administration in the first
quarter of 2027.
A
copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
The
information 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 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.
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 1, 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 1, 2026 |
By: |
/s/ Erez Aminov |
| |
Name: |
Erez Aminov |
| |
Title: |
Chief Executive Officer |
Exhibit 99.1
MIRA
Pharmaceuticals Advances Non-Opioid Oral MIRA-55 for Inflammatory Pain Toward IND
Positive
Toxicology Results From 7-Day Rat and Dog Studies Characterize Tolerability and Inform Dose Selection for Next Phase of IND-Enabling
Program, Targeting Q1 2027 IND Submission
MIAMI,
Sept. 1, 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 positive results from completed 7-day dose-range
finding toxicology and toxicokinetic studies of MIRA-55 in rats and dogs. MIRA-55 is the Company’s investigational oral, non-opioid drug
candidate being developed for inflammatory pain.
Cross-Species
Study Findings
The
completed studies characterized tolerability, toxicity, and systemic exposure across both species. Rats were identified as the more sensitive
species, while dogs demonstrated greater tolerance across the dose levels studied. Toxicokinetic analyses confirmed systemic exposure
in both species and characterized how exposure changed with dose and repeated administration.
Importantly,
the studies achieved their intended dose-range finding objective by generating the cross-species information needed to guide dose selection
for the next phase of MIRA-55’s ongoing IND-enabling program. The Company plans to use these findings to inform the design of subsequent
GLP-compliant toxicology studies.
“Inflammatory
pain is a massive unmet need affecting millions of patients globally, and current treatments carry significant liabilities that drive
patients to seek alternatives. MIRA-55 represents a genuine opportunity to address that need with a differentiated approach. These tox
results are an important milestone as we move toward human studies,” said Erez Aminov, CEO of MIRA.
“MIRA-55
was designed to provide a differentiated approach to inflammatory pain by modulating cannabinoid pathways involved in both pain signaling
and inflammation,” said Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA. “The results of these studies further characterize
the compound’s tolerability and systemic exposure across species and add to a broader preclinical profile that has demonstrated
analgesic and anti-inflammatory activity, while prior behavioral studies showed that MIRA-55 did not produce the characteristic CNS effects
associated with THC. Taken together, these findings strengthen the scientific foundation for continued IND-enabling development.”
A
Significant Need for New Non-Opioid Pain Treatments
The
need for new approaches to pain management remains substantial. In 2023, 24.3% of U.S. adults experienced chronic pain, including 8.5%
who experienced high-impact chronic pain that frequently limited life or work activities, according to the U.S. Centers for Disease Control
and Prevention.
The
global non-opioid pain-treatment market was valued at approximately $45.3 billion in 2024 and is projected to reach approximately $70.3
billion by 2030, representing a projected compound annual growth rate of approximately 7.7%, according to Grand View Research.
MIRA-55
is being developed within this landscape as an investigational oral, non-opioid therapy for inflammatory pain. In previously reported
preclinical studies conducted separately from the toxicology studies announced today, oral MIRA-55 normalized pain responses and significantly
reduced inflammation in a validated inflammatory pain model, outperforming injected morphine in pain normalization.
MIRA
believes this combination of analgesic and anti-inflammatory activity represents a differentiated approach to inflammatory pain, where
the goal is not only to address pain signaling but also the inflammatory processes contributing to pain.
Next
Steps
MIRA
plans to use the completed dose-range finding data to support the next phase of its ongoing IND-enabling toxicology program.
In
parallel, the Company has successfully advanced manufacturing scale-up and formulation work for MIRA-55 in support of its broader preparations
for clinical development.
Subject
to successful completion of the remaining IND-enabling studies, applicable regulatory requirements and other development considerations,
the Company is targeting submission of an Investigational New Drug application for MIRA-55 to the U.S. Food and Drug Administration in
the first quarter of 2027.
About
MIRA-55
MIRA-55
is an investigational oral small-molecule drug candidate being developed as a potential non-opioid therapy for inflammatory pain. The
compound is designed to modulate cannabinoid receptor pathways associated with pain and inflammation while minimizing the characteristic
psychoactive effects associated with THC.
In
previously reported preclinical studies, oral MIRA-55 demonstrated analgesic and anti-inflammatory activity, including normalization
of pain responses and reductions in inflammation in a validated inflammatory pain model. Additional behavioral and mechanistic studies
showed that MIRA-55 did not produce the characteristic CNS effects associated with THC and demonstrated a differentiated pharmacological
profile.
Following
scientific review, the U.S. Drug Enforcement Administration 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. 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
