Did MIRA (MIRA) report effects of SKNY-1 on addiction-related behaviors?

Yes. The manuscript describes attenuation of compulsive feeding and nicotine-seeking behaviors in multiple zebrafish behavioral paradigms. These findings relate to reward-associated behaviors in an animal model and do not establish clinical efficacy for addiction treatment in humans.

MIRA details preclinical SKNY-1 obesity data

MIRA Pharmaceuticals filed an 8-K to highlight new preclinical data on SKNY-1, its investigational oral drug candidate for obesity and nicotine addiction.

Accepted by SEC EDGAR 05/13/2026 - 07:30 AM EDT

Filing Impact

(Moderate)

Filing Sentiment

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Form Type

8-K

Rhea-AI Filing Summary

MIRA Pharmaceuticals filed an 8-K to highlight new preclinical data on SKNY-1, its investigational oral drug candidate for obesity and nicotine addiction. A peer-reviewed manuscript in the International Journal of Molecular Sciences describes SKNY-1’s pharmacology and effects in an MC4R-deficient zebrafish obesity model.

The study reports that oral SKNY-1 produced dose-dependent weight loss over six days, including about a 30% reduction in body weight from baseline in the higher-dose group, with no significant reduction in whole-body density. It also details improvements in cholesterol measures, liver triglycerides, appetite-related gene expression, and compulsive feeding and nicotine-seeking behaviors.

The company emphasizes these findings are from zebrafish and in vitro systems only. SKNY-1 is not FDA approved, and its safety and efficacy in humans are not established.

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.

Key Figures

Weight reduction at higher SKNY-1 dose: approximately 30% reduction in body weight Treatment duration: six days Journal reference: MDPI IJMS 27(10):4321

3 metrics

Weight reduction at higher SKNY-1 dose approximately 30% reduction in body weight Higher-dose zebrafish group after six days of oral treatment

Treatment duration six days Oral SKNY-1 administration period in zebrafish study

Journal reference MDPI IJMS 27(10):4321 Publication citation for SKNY-1 zebrafish manuscript

Key Terms

cannabinoid receptor 1 (CB1), cannabinoid receptor 2 (CB2), monoamine oxidase B (MAO-B), MC4R-deficient zebrafish model, +1 more

5 terms

cannabinoid receptor 1 (CB1) medical

"SKNY-1 demonstrated differential engagement of cannabinoid receptor 1 (CB1) signaling pathways"

Cannabinoid receptor 1 (CB1) is a protein on cells, especially in the brain and nervous system, that acts like a lock for cannabis-like chemicals and naturally produced signals; when activated it influences appetite, pain, mood and memory. Investors track CB1 because it is a major drug target—therapies that block or stimulate it can create new treatments but also carry safety and regulatory risks, so trial results and patents materially affect company value.

cannabinoid receptor 2 (CB2) medical

"partial agonist activity at cannabinoid receptor 2 (CB2)"

Cannabinoid receptor 2 (CB2) is a protein found mainly on immune cells that acts like a lock on the cell surface, responding to natural or drug-made molecules to change how the cell behaves. Investors watch CB2 because it is a common drug target for treatments aimed at inflammation, pain and immune-related diseases; success or failure in developing CB2-targeting drugs can strongly affect a company’s clinical prospects, regulatory risk and potential market value.

monoamine oxidase B (MAO-B) medical

"selective in vitro inhibition of monoamine oxidase B (MAO-B) relative to MAO-A"

Monoamine oxidase B (MAO-B) is an enzyme in the brain and other tissues that breaks down certain mood- and movement-related chemicals, including dopamine. For investors, MAO-B matters because medicines that block or alter its activity are common drug targets for neurological conditions; successful inhibitors can drive prescription sales but also carry safety and interaction risks that affect regulatory approval, commercial value, and patent economics.

MC4R-deficient zebrafish model medical

"in an MC4R-deficient zebrafish model exhibiting obesity-associated metabolic and reward-related phenotypes"

leptin and ghrelin gene expression medical

"modulation of leptin and ghrelin gene expression patterns"

FAQ

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

What did MIRA (MIRA) disclose about SKNY-1 in this 8-K filing?

MIRA reported a peer-reviewed publication on SKNY-1, its investigational oral drug for obesity and nicotine addiction. The study in zebrafish showed weight loss, metabolic improvements, and behavioral effects, but SKNY-1 remains preclinical and unproven in humans.

What preclinical weight loss results did SKNY-1 show for MIRA (MIRA)?

The zebrafish study found oral SKNY-1 led to dose-dependent weight loss over six days, including about a 30% body weight reduction at a higher dose. These results are limited to an MC4R-deficient zebrafish obesity model, not human patients.

How did SKNY-1 affect cholesterol and liver fat in MIRA (MIRA) research?

The publication reports SKNY-1 normalized total cholesterol and LDL, increased HDL, and reduced hepatic triglyceride accumulation in the zebrafish obesity model. These metabolic changes were observed only in preclinical animal testing and do not demonstrate human benefit.

Is SKNY-1 approved by the FDA according to MIRA (MIRA)?

No. The filing states SKNY-1 has not been approved by the U.S. Food and Drug Administration for any indication. Its safety and efficacy have not been established in humans, and current evidence comes from zebrafish and in vitro experiments.

Where can investors read the SKNY-1 manuscript mentioned by MIRA (MIRA)?

The company notes the SKNY-1 paper is available online in the International Journal of Molecular Sciences, published by MDPI. The filing provides a direct URL to the article for readers who want full experimental details and data tables.

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

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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: May 12, 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

On May 13, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) announced the publication of a peer-reviewed manuscript relating to SKNY-1, the Company’s investigational oral drug candidate being evaluated for obesity and nicotine addiction, in the International Journal of Molecular Sciences.

The manuscript, titled “SKNY-1, a THCV Analog, Produces Weight Loss, Lipid Normalization and Attenuation of Reward-Associated Behaviors in an mc4r(G894C) Zebrafish Model of Obesity,” describes preclinical in vitro pharmacologic characterization and in vivo findings observed in an MC4R-deficient zebrafish model exhibiting obesity-associated metabolic and reward-related phenotypes.

According to the publication, SKNY-1 demonstrated differential engagement of cannabinoid receptor 1 (CB1) signaling pathways, partial agonist activity at cannabinoid receptor 2 (CB2), and selective in vitro inhibition of monoamine oxidase B (MAO-B) relative to MAO-A.

The publication further reports that oral administration of SKNY-1 in the evaluated preclinical model was associated with dose-dependent reductions in body weight following six days of treatment, including approximately 30% reduction relative to baseline in the higher-dose group. The manuscript also reports no significant reduction in whole-body density during the treatment period.

Additional findings described in the publication include normalization of total cholesterol and low-density lipoprotein (LDL) levels, increased high-density lipoprotein (HDL) levels, reduction of hepatic triglyceride accumulation, modulation of leptin and ghrelin gene expression patterns, and attenuation of compulsive feeding and nicotine-seeking behaviors in multiple behavioral paradigms.

The Company previously reported additional preclinical behavioral findings consistent with SKNY-1’s differentiated CB1 pathway engagement, including attenuation of anxiety-like behaviors in a validated zebrafish behavioral model evaluating cannabinoid-related central nervous system effects.

The publication is available online through MDPI at https://www.mdpi.com/1422-0067/27/10/4321.

The findings described in the publication are based on preclinical research conducted in zebrafish models and in vitro systems. SKNY-1 has not been approved by the U.S. Food and Drug Administration (“FDA”) for any indication, and the safety and efficacy of SKNY-1 have not been established in humans.

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: May 13, 2026	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

3 documents