MIRA Pharmaceuticals reports new Mira-55 CNS data

MIRA Pharmaceuticals reported new preclinical results for its candidate Mira-55, showing no THC- or rimonabant-associated central nervous system side effects in established behavioral assays at oral doses of 10, 30, and 100 mg/kg.

Rhea-AI Filing Summary

MIRA Pharmaceuticals reported new preclinical results for its candidate Mira-55, showing no THC- or rimonabant-associated central nervous system side effects in established behavioral assays at oral doses of 10, 30, and 100 mg/kg.

Mira-55 did not produce cannabinoid-like psychogenic, sedative, cataleptic, motor, or anxiogenic effects and showed reduced anxiety-like behavior in the Elevated Plus Maze, while rimonabant produced anxiety-like changes. These findings build on earlier data where Mira-55 delivered morphine-comparable analgesia in a validated inflammatory pain model without opioid-related risks. The company is advancing Mira-55 toward an Investigational New Drug submission for inflammatory pain and continuing additional preclinical studies.

Insights

Biotech and drug development analyst

Early preclinical data for Mira-55 show encouraging CNS tolerability alongside prior analgesic signals.

MIRA Pharmaceuticals presents preclinical behavioral data suggesting Mira-55 does not show THC- or rimonabant-like central nervous system side effects at tested oral doses. Assays covered psychogenic, motor, and anxiety-like behaviors, including Elevated Plus Maze and Open Field testing, which are standard cannabinoid-related models.

The company links these findings to previously reported morphine-comparable analgesic effects in an inflammatory pain model without opioid-related risks. Together, the dataset supports the stated plan to move toward an Investigational New Drug submission for inflammatory pain, although this remains at a nonclinical stage with future outcomes dependent on subsequent studies and regulatory review.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

FAQ

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What did MIRA (MIRA) announce about Mira-55 in this 8-K filing?

MIRA announced new preclinical data showing Mira-55 did not exhibit THC- or rimonabant-associated CNS side effects in multiple behavioral assays. These results complement earlier findings of morphine-comparable pain relief in an inflammatory pain model without opioid-related risks, supporting a planned IND submission for inflammatory pain.

What CNS and behavioral effects were evaluated for Mira-55 by MIRA (MIRA)?

MIRA evaluated Mira-55 in hypothermia, catalepsy, Elevated Plus Maze, and Open Field assays commonly used for cannabinoid-related side effects. The data showed no psychogenic, sedative, cataleptic, motor, or anxiogenic effects at tested doses, contrasting with rimonabant’s anxiety-like behavioral changes in the same models.

How did Mira-55 perform in anxiety-related tests reported by MIRA (MIRA)?

In the Elevated Plus Maze, Mira-55 produced a dose-dependent increase in time spent in open arms, consistent with reduced anxiety-like behavior. In Open Field testing, Mira-55 groups resembled vehicle controls, while rimonabant-treated groups spent less time in the center, indicating anxiety-like behavior and confirming model sensitivity.

What prior pain data for Mira-55 did MIRA (MIRA) reference?

MIRA referenced previously reported preclinical data where Mira-55 produced morphine-comparable analgesic effects in a validated inflammatory pain model. The compound reduced pain sensitivity and restored thresholds to near-baseline levels, while avoiding opioid-related risks, forming part of the rationale for advancing it in inflammatory pain.

What are MIRA’s (MIRA) next planned steps for Mira-55?

MIRA stated it is advancing Mira-55 toward an Investigational New Drug submission for inflammatory pain. The company is also conducting additional preclinical studies to further support potential future clinical development, building on both the analgesic and CNS tolerability data disclosed for this candidate.

How were Mira-55 doses structured in MIRA’s (MIRA) preclinical study?

The preclinical study evaluated oral Mira-55 at 10, 30, and 100 mg/kg doses, alongside THC and rimonabant comparators. These dosing levels were tested across several behavioral assays to assess cannabinoid-related CNS and behavioral side effects, including psychogenic, motor, and anxiety-like responses in validated models.

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Accepted by SEC EDGAR 03/23/2026 - 09:00 AM Learn about SEC filing dates

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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: March 23, 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)

(786) 432-9792

(Registrant’s telephone

number, including area code)

(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 8.01 Other Events

MIRA Pharmaceuticals Reports Mira-55 Shows No THC- or Rimonabant-Associated CNS Side Effects in Preclinical Studies

Previously shown to deliver morphine-comparable pain relief without opioid-related risks in a validated inflammatory pain model, supporting planned IND submission for inflammatory pain.

On March 23, 2026, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (the “Company”) is reporting new preclinical data evaluating the central nervous system (CNS) and behavioral effects of Mira-55 in a series of established assays commonly used to assess cannabinoid-related side effects.

The study, conducted in collaboration with Pharmaseed, evaluated oral Mira-55 at doses of 10, 30, and 100 mg/kg and included comparisons to Δ9-tetrahydrocannabinol (THC) and the CB1 receptor antagonist rimonabant. The assessment included hypothermia, catalepsy, Elevated Plus Maze (EPM), and Open Field (OF) assays, which are commonly used to evaluate cannabinoid-related psychogenic, motor, and anxiety-like effects.

Study Results:

	●	Mira-55 did not produce cannabinoid-like psychogenic effects at any tested dose.
	●	No evidence of sedation, catalepsy, or motor impairment was observed.
	●	No anxiogenic effects were observed, in contrast to rimonabant, which demonstrated anxiety-like behavioral changes.
	●	In the Elevated Plus Maze (EPM), Mira-55 showed a dose-dependent increase in time spent in open arms, consistent with reduced anxiety-like behavior.
	●	In Open Field (OF) testing, Mira-55-treated groups were comparable to vehicle controls. Rimonabant-treated groups demonstrated reduced time spent in the center of the open field, a commonly used indicator of anxiety-like behavior, supporting the sensitivity of the experimental model.
	●	These findings build on previously reported preclinical data demonstrating that Mira-55 produced morphine-comparable analgesic effects in a validated model of inflammatory pain, reducing pain sensitivity and restoring thresholds to near-baseline levels, without opioid-related risks.

The Company is advancing Mira-55 toward an Investigational New Drug (IND) submission for inflammatory pain and continues to conduct additional preclinical studies to support potential future clinical development.

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 PHARMACUTICALS, INC.
Dated: March 23, 2026	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

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