MIRA: Oral Mira-55 tops morphine in pain model; eyes IND

MIRA Pharmaceuticals reported new preclinical results showing its oral candidate Mira-55, a non-psychotropic marijuana analog, outperformed injected morphine in an established animal model of chronic inflammatory pain.

Rhea-AI Filing Summary

MIRA Pharmaceuticals reported new preclinical results showing its oral candidate Mira-55, a non-psychotropic marijuana analog, outperformed injected morphine in an established animal model of chronic inflammatory pain. The study found oral Mira-55 fully normalized pain thresholds and significantly reduced inflammation, while morphine delivered only partial, indirectly mediated swelling reduction.

This is the first time the program directly measured inflammation alongside pain. The data support a CB2 receptor–mediated anti-inflammatory mechanism and back the company’s plan to pursue an IND for chronic inflammatory pain. MIRA frames Mira-55 within the non-opioid pain space, noting a $70 billion market opportunity.

Key takeaways include pain normalization, inflammation reduction, and the potential convenience of oral administration versus injections. The company positions Mira-55’s dual approach—addressing both pain perception and inflammation—as a differentiated path in chronic inflammatory pain.

Insights

Biotech R&D Analyst

Preclinical oral efficacy and anti-inflammatory signal support an IND path.

The results indicate oral Mira-55 normalized pain thresholds and reduced inflammation in a chronic inflammatory pain animal model, while injected morphine achieved only partial swelling reduction. The study newly measured inflammation, aligning with a CB2 receptor mechanism that targets both pain and inflammatory drivers.

Because these are preclinical animal data, translational outcomes remain uncertain until human studies commence under an IND. The oral route could be clinically convenient if efficacy and safety translate, especially relative to injection-dependent comparators.

On October 15, 2025, the company linked the findings to its planned IND for chronic inflammatory pain and referenced a $70 billion non-opioid pain market. Actual clinical progress will depend on subsequent regulatory interactions and trial results.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did MIRA (MIRA) announce about Mira-55?

MIRA reported preclinical data showing oral Mira-55 fully normalized pain and significantly reduced inflammation in an animal model, outperforming injected morphine.

How does Mira-55 compare to morphine in the study?

Oral Mira-55 outperformed injected morphine by normalizing pain thresholds and directly reducing inflammation; morphine only partially reduced swelling via indirect effects.

What mechanism does Mira-55 target?

The findings support a CB2 receptor–mediated anti-inflammatory mechanism, addressing both pain perception and inflammation.

What is the next step for Mira-55?

The results support the company’s plan to pursue an IND application for chronic inflammatory pain.

Why is oral administration notable for Mira-55?

The data highlight efficacy via oral dosing, which may offer clinical convenience compared with agents requiring injection.

What market context did MIRA mention?

MIRA referenced participation in a non-opioid pain market described as about $70 billion.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 10/15/2025 - 12:00 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 (Date of earliest event reported): October 15, 2025

MIRA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

Florida		001-41765		85-3354547
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer 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 8.01 Other Events

MIRA Pharmaceuticals Announces Oral Mira-55 Outperformed Injected Morphine in Normalizing Pain and Reducing Inflammation, Supporting Its Planned IND for Chronic Inflammatory Pain

Findings show oral Mira-55 fully normalized pain and significantly reduced inflammation, supporting IND plans and reinforcing MIRA’s position in a $70 billion non-opioid pain market.

On October 15, 2025, MIRA Pharmaceuticals, Inc. (the “Company”) announced new preclinical data for Mira-55, its proprietary non-psychotropic marijuana analog, showing that oral administration of Mira-55 normalized pain and significantly reduced inflammation, outperforming injected morphine in an established animal model of chronic inflammatory pain.

This study marks the first time inflammation was directly measured alongside pain in the Mira-55 program. In the Company’s prior study, only pain sensitivity was assessed, with both Mira-55 and morphine administered by injection. The new data demonstrate that orally administered Mira-55 provided superior pain normalization and direct anti-inflammatory effects, while morphine produced only partial and indirect inflammation reduction.

Key observations from the study include:

	●	Pain normalization: Oral Mira-55 restored pain thresholds to baseline levels and outperformed injected morphine in reversing formalin-induced pain sensitivity.
	●	Inflammation reduction: Mira-55 significantly reduced paw edema, confirming a direct CB2-receptor-mediated anti-inflammatory mechanism, whereas morphine reduced swelling only partially through indirect, centrally mediated effects.
	●	Oral advantage: Mira-55’s efficacy via oral administration highlights a potential clinical convenience compared with morphine, which required injection to achieve its effects.

Reducing inflammation is fundamental to treating pain effectively. Inflammation drives nerve sensitization and amplifies pain signaling. Opioids block pain perception in the brain but do not treat inflammation, while NSAIDs address inflammation but carry safety concerns. By directly targeting inflammation through CB2 receptor activation, Mira-55 addresses both the cause and the perception of pain, offering a differentiated dual mechanism for chronic inflammatory pain conditions.

These findings support the Company’s plan to pursue an Investigational New Drug (IND) application for chronic inflammatory pain and strengthen the scientific basis for advancing Mira-55 within its non-opioid pain franchise.

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 15, 2025	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer