MIRA Pharmaceuticals (MIRA) reports promising SKNY-1 preclinical pharmacokinetic and behavioral data

(High)

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

MIRA Pharmaceuticals, Inc. reported new preclinical results for its oral drug candidate SKNY-1, being developed for obesity and addiction-related disorders. The optimized oral formulation showed favorable oral bioavailability, reproducible systemic exposure, robust brain penetration, and substantial liver exposure, supporting the potential for convenient once-daily dosing.

The company said these pharmacokinetic findings strengthen SKNY-1’s development profile and complement earlier preclinical data showing reduced body weight, preserved lean mass, improved metabolic measures, reduced compulsive feeding and nicotine-seeking behaviors, and no anxiety-related behavioral effects despite cannabinoid receptor activity. The details were shared via a press release furnished as an exhibit.

Insights

MIRA highlights encouraging preclinical pharmacokinetic data for SKNY-1 that support once-daily oral development.

MIRA Pharmaceuticals furnished an update on SKNY-1, its oral candidate for obesity and addiction-related disorders. New preclinical studies showed favorable oral bioavailability, consistent systemic exposure, robust brain penetration, and substantial liver exposure, all important for a centrally active metabolic drug.

The company said peak plasma concentrations and kinetics support the potential for once-daily oral dosing, which could be commercially attractive if later efficacy and safety data align. These pharmacokinetic results are described as strengthening SKNY-1’s profile alongside earlier preclinical efficacy and behavioral findings.

The information is furnished under a Regulation FD disclosure, without financial metrics or clinical outcomes. Actual impact will depend on future development steps and how these preclinical properties translate into human studies, which are not described in this summary.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Terms

Regulation FD Disclosure, preclinical studies, oral bioavailability, pharmacokinetic findings, +1 more

5 terms

Regulation FD Disclosure regulatory

"Item 7.01 Regulation FD Disclosure. On July 6, 2026, MIRA Pharmaceuticals, Inc..."

Regulation FD disclosure requires public companies to share important, market-moving information with everyone at the same time instead of tipping off analysts or large investors first. Think of it as making sure all players on a field hear the same announcement simultaneously; that fairness helps investors trust that stock prices reflect the same information and reduces the risk of sudden, unfair trading advantages or regulatory penalties for selective leaks.

preclinical studies financial

"issued a press release announcing positive results from preclinical studies evaluating the optimized oral formulation of SKNY-1"

Preclinical studies are initial research tests conducted in laboratories and on animals to evaluate the safety, effectiveness, and potential risks of a new medical treatment or drug before it is tested in humans. For investors, these studies are an important early step that can indicate whether a product has the potential to advance toward approval and commercial use, influencing the future prospects and valuation of related companies.

oral bioavailability technical

"The studies demonstrated favorable oral bioavailability together with reproducible systemic exposure"

Oral bioavailability is the share of a pill or liquid medicine that survives the digestive system and reaches the bloodstream to have an effect. It matters to investors because low bioavailability can mean higher doses, more side effects, tougher manufacturing, and greater clinical or regulatory risk, all of which affect a drug’s cost, pricing and commercial prospects—like ordering a package and finding only part of it arrives.

pharmacokinetic findings technical

"The Company believes these pharmacokinetic findings further strengthen the development profile of SKNY-1"

cannabinoid receptor activity technical

"evidence that SKNY-1 did not produce anxiety-related behavioral effects ... despite demonstrated cannabinoid receptor activity"

FAQ

What did MIRA (MIRA) announce about its SKNY-1 drug candidate?

MIRA announced positive preclinical results for SKNY-1, its oral candidate for obesity and addiction-related disorders. The studies showed favorable oral bioavailability, reproducible systemic exposure, strong brain penetration, and substantial liver exposure, supporting the potential for convenient once-daily oral dosing according to the company.

What conditions is MIRA’s SKNY-1 being developed to treat?

SKNY-1 is being developed by MIRA for obesity and addiction-related disorders. The company highlighted preclinical efficacy and behavioral data showing reduced body weight, preserved lean body mass, improved metabolic parameters, and attenuation of compulsive feeding and nicotine-seeking behaviors in preclinical models.

What pharmacokinetic results did MIRA report for SKNY-1?

MIRA reported that SKNY-1’s optimized oral formulation demonstrated favorable oral bioavailability, reproducible systemic exposure, robust brain penetration, and substantial liver exposure. Peak plasma concentrations and kinetics were described as supporting the potential for once-daily dosing, which the company believes strengthens SKNY-1’s development profile.

How do the new SKNY-1 findings relate to MIRA’s earlier preclinical data?

The new pharmacokinetic findings are said to complement earlier preclinical efficacy and behavioral data. Those prior studies showed significant body weight reductions, preserved lean mass, better metabolic measures, reduced compulsive feeding and nicotine-seeking, and no anxiety-like behaviors despite demonstrated cannabinoid receptor activity in a validated model.

How were the SKNY-1 preclinical results disclosed by MIRA (MIRA)?

MIRA shared the SKNY-1 preclinical results through a press release furnished as Exhibit 99.1 to a current report. The company specified that this information is furnished under Regulation FD and is not deemed filed for liability purposes under Section 18 of the Exchange Act.

Did MIRA report any financial results in this SKNY-1 update?

The disclosure focuses on preclinical and pharmacokinetic results for SKNY-1 and does not include financial metrics. It is presented as a Regulation FD information update, with the full details contained in an attached press release referenced as an exhibit to the report.

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

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Available on EDGAR 07/06/2026 - 09:00 AM Accepted by SEC EDGAR 07/06/2026 - 09:00 AM

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 6, 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 6, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive results from preclinical studies evaluating the optimized oral formulation of SKNY-1, the Company’s oral drug candidate being developed for obesity and addiction-related disorders.

The studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial liver exposure following oral administration. Peak plasma concentrations and kinetics supported the potential for convenient once-daily oral dosing.

The Company believes these pharmacokinetic findings further strengthen the development profile of SKNY-1 by demonstrating that the optimized oral formulation delivers meaningful systemic exposure together with distribution into pharmacologically relevant tissues. These findings complement the Company’s previously reported preclinical efficacy and behavioral studies demonstrating significant reductions in body weight, preservation of lean body mass, improvements in metabolic parameters, attenuation of compulsive feeding and nicotine-seeking behaviors, and evidence that SKNY-1 did not produce anxiety-related behavioral effects in a validated preclinical model despite demonstrated cannabinoid receptor activity.

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 6, 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 6, 2026	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Press Releases

EX-99.1 EX-99.1 25.3 KB

MIRA Pharmaceuticals (MIRA) reports promising SKNY-1 preclinical pharmacokinetic and behavioral data

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