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MIRA Pharmaceuticals (NASDAQ: MIRA) advances SKNY-1 after 7-day dog study

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

MIRA Pharmaceuticals, Inc. reported new preclinical data for SKNY-1, its investigational oral obesity candidate designed to promote weight loss while preserving lean body mass. In a 7-day repeated-dose study in male and female Beagle dogs, SKNY-1 showed rapid oral absorption and dose-dependent systemic exposure across the evaluated dose range, with comparable plasma concentrations between sexes.

The company states that the toxicokinetic results demonstrate dose-dependent response and systemic accumulation with repeated dosing, providing confidence in dose selection for a planned GLP toxicology program. MIRA believes these findings de-risk dose selection and support advancement toward GLP-compliant toxicology studies required for IND-enabling development, while noting that additional preclinical efficacy and safety work is needed as it advances SKNY-1 and its broader pipeline, which includes MIRA-55 and Ketamir-2.

Positive

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Negative

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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, and exhibit attachments filed with this report.
Study duration 7 days Duration of repeated daily oral dosing of SKNY-1 in Beagle dogs
Dosing frequency daily oral dosing Study evaluated repeated daily oral dosing in male and female Beagle dogs
Par value per share $0.0001 per share Par value of MIRA Pharmaceuticals common stock
Commission File Number 001-41765 SEC Commission File Number for MIRA Pharmaceuticals, Inc.
toxicokinetic medical
"announcing positive toxicokinetic findings from a 7-day repeated-dose study"
Toxicokinetic describes how a chemical or drug that can cause harm is absorbed, spread, changed, and removed by the body—essentially tracking the journey and concentration of a potentially toxic substance over time. Investors care because these results shape a product’s safety profile, dosing rules and regulatory odds; strong toxicokinetic data reduces surprise risks much like tracking a package reduces the chance it gets lost or damaged.
GLP toxicology regulatory
"support advancement toward GLP toxicology studies and IND-enabling development"
GLP toxicology are safety studies conducted under Good Laboratory Practice, a set of quality rules that make sure experiments on a drug, chemical, or product are carried out, recorded and reported reliably. For investors, GLP toxicology is important because it provides trusted evidence about potential harms that regulators use to decide whether a product can proceed, much like audited crash tests that signal whether a product is safe enough to sell.
IND-enabling development regulatory
"support advancement toward GLP toxicology studies and IND-enabling development"
chemotherapy-induced peripheral neuropathy medical
"Ketamir-2 for chemotherapy-induced peripheral neuropathy (CIPN)"
Nerve damage caused by certain cancer drugs that produces numbness, tingling, pain or weakness in the hands and feet; think of it like electrical wiring in the body becoming frayed and sending poor signals. It matters to investors because this side effect can force dose cuts, treatment delays, or additional care, affecting a drug’s safety profile, clinical trial results, patient demand and overall healthcare costs — all of which influence a company’s revenue and regulatory prospects.
compulsive feeding behavior medical
"The compound attenuated compulsive feeding behavior in validated experimental models"
cannabinoid pathways medical
"despite engaging central cannabinoid pathways, distinguishing it from earlier CB1 therapies"

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FAQ

What did MIRA (MIRA) announce about SKNY-1 in its latest 8-K?
MIRA Pharmaceuticals announced positive toxicokinetic findings from a 7-day repeated-dose SKNY-1 study in Beagle dogs, showing rapid absorption, dose-dependent systemic exposure, and systemic accumulation that support dose selection for planned GLP toxicology work.

What is SKNY-1 and what obesity problem is MIRA (MIRA) targeting?
SKNY-1 is an investigational oral drug candidate for obesity that aims to reduce body weight while preserving lean body mass. MIRA highlights current obesity treatments often involve lean muscle loss, and SKNY-1 is being developed to address that limitation.

What were the key results from the 7-day Beagle dog study of SKNY-1 by MIRA (MIRA)?
The 7-day Beagle dog study showed rapid oral absorption, dose-dependent systemic exposure, and systemic accumulation with repeated dosing. Plasma concentrations were comparable in male and female dogs, helping inform dose selection for GLP-compliant toxicology studies.

How do the SKNY-1 dog-study results affect MIRA’s (MIRA) IND-enabling plans?
MIRA states that the toxicokinetic findings de-risk dose selection and support advancing SKNY-1 toward GLP-compliant toxicology studies required for IND-enabling development. These data will guide dose and study design in the upcoming nonclinical toxicology program.

What other pipeline programs besides SKNY-1 does MIRA (MIRA) highlight?
MIRA highlights Ketamir-2 for chemotherapy-induced peripheral neuropathy, which has completed Phase 1 and is advancing toward Phase 2a, and MIRA-55, an investigational oral candidate for chronic inflammatory pain, alongside SKNY-1 for obesity.

Are MIRA’s (MIRA) drug candidates considered controlled substances by the DEA?
MIRA states that, following scientific review, the U.S. Drug Enforcement Administration determined Ketamir-2, MIRA-55 and SKNY-1 are not classified as controlled substances, which clarifies their regulatory handling from a controlled-substance standpoint.
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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): August 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 August 6, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing positive toxicokinetic findings from a 7-day repeated-dose study of SKNY-1 in Beagle dogs. SKNY-1 is an investigational oral drug candidate being developed for obesity, which aims to preserve lean body mass while promoting weight reduction.

 

The study evaluated SKNY-1 following repeated daily oral dosing in male and female Beagle dogs over 7 days. SKNY-1 demonstrated rapid oral absorption and dose-dependent systemic exposure across the evaluated dose range. Plasma concentrations were comparable between male and female animals. The data demonstrates evidence of dose-dependent response and systemic accumulation with repeated dosing, providing confidence in dose selection for the planned GLP toxicology program.

 

The Company believes these toxicokinetic findings de-risk dose selection and support advancement toward GLP-compliant toxicology studies required for IND-enabling development. These findings are based on preclinical toxicokinetic studies, and additional preclinical efficacy and safety studies will be required to further characterize SKNY-1 as the Company advances its IND-enabling program. 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 August 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: August 6, 2026 By: /s/ Erez Aminov
  Name: Erez Aminov
  Title: Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

MIRA Reports Positive 7-Day Dog Study Results for SKNY-1—Obesity Treatment Designed to Preserve Lean Body Mass

 

Toxicokinetic Findings De-Risk Dose Selection and Support Regulatory Pathway Toward IND

 

MIAMI, August 6, 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 toxicokinetic findings from a 7-day repeated-dose study of SKNY-1 in Beagle dogs. The study demonstrates dose-dependent systemic exposure and rapid absorption that de-risk dose selection and support advancement toward GLP toxicology studies and IND-enabling development.

 

The study evaluated SKNY-1 following repeated daily oral dosing in male and female Beagle dogs over 7 days. SKNY-1 demonstrated rapid oral absorption and dose-dependent systemic exposure across the evaluated dose range. Plasma concentrations were comparable between male and female animals.

 

The data demonstrates evidence of dose-dependent response and systemic accumulation with repeated dosing, providing confidence in dose selection for the planned GLP toxicology program.

 

“Obesity treatments today often come at the cost of lean muscle loss, which undermines long-term health outcomes,” said Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals. “SKNY-1 aims to solve that problem. These toxicokinetic findings de-risk our dose selection, and we’re excited to continue advancing SKNY-1 toward IND-enabling development.”

 

Dr. Itzchak Angel, Chief Scientific Advisor of MIRA, added: “Characterizing systemic exposure in a larger animal species is essential for translating to humans. The dose-dependent relationship and rapid absorption in dogs further strengthen our development package and support advancement toward GLP toxicology studies.”

 

These toxicokinetic findings will inform dose selection and study design for the Company’s planned GLP-compliant toxicology program. MIRA is advancing SKNY-1 through additional preclinical efficacy and safety studies to build a comprehensive nonclinical package supporting IND-enabling development for obesity.

 

About SKNY-1

 

In peer-reviewed preclinical studies published in the International Journal of Molecular Sciences, oral SKNY-1 demonstrated dose-dependent reductions in body weight while preserving lean body mass, along with lipid normalization and reduced hepatic triglyceride accumulation. The compound attenuated compulsive feeding behavior in validated experimental models. In separate behavioral studies, SKNY-1 was devoid of anxiety-related effects despite engaging central cannabinoid pathways, distinguishing it from earlier CB1-targeting therapies. A lead oral formulation demonstrated favorable bioavailability with robust brain penetration and substantial liver exposure, supporting once-daily oral dosing potential.

 

 
 

 

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 chronic 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.

 

Contact:

 

Krystina Quintana
MIRA Pharmaceuticals
info@mirapharma.com
(786) 432-9792

 

 

 

Source: View Original Filing on SEC EDGAR

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