The Albany Gazette - MIRA Pharmaceuticals Announces Acceptance of Peer-Reviewed SKNY-1 Manuscript Highlighting Oral Obesity and Nicotine Addiction Drug Candidate

MIAMI, FL / ACCESS Newswire / May 13, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on the development of investigational therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced the acceptance and publication of a peer-reviewed manuscript describing the preclinical pharmacology and activity of SKNY-1, the Company's oral investigational drug candidate being evaluated for obesity and nicotine addiction, in the International Journal of Molecular Sciences.

The publication, 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 in vitro pharmacologic characterization and in vivo preclinical findings observed in an MC4R-deficient zebrafish model exhibiting obesity-associated metabolic and reward-related phenotypes.

The full publication is available online through MDPI at International Journal of Molecular Sciences publication.

"Despite significant advances in obesity treatment, existing therapeutic approaches continue to face limitations related to tolerability, long-term adherence, durability of response, and increasing clinical focus on preservation of lean body mass during weight reduction," said Erez Aminov, CEO of MIRA. "We believe the publication of these peer-reviewed findings further supports the differentiated pharmacological profile of SKNY-1 and its potential as a novel oral investigational approach targeting both metabolic and reward-associated pathways."

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 manuscript further reports that oral administration of SKNY-1 in the mc4r(G894C) zebrafish model was associated with dose-dependent reductions in body weight, modulation of lipid parameters, reduction of hepatic triglyceride accumulation, and attenuation of compulsive feeding and nicotine-seeking behaviors.

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.

Key findings described in the publication include:

• Dose-dependent reduction in body weight following six days of oral administration, with the higher dose group demonstrating approximately 30% reduction relative to baseline.

• No significant reduction in whole-body density observed during the treatment period.

• Reductions in total cholesterol, low-density lipoprotein (LDL), and hepatic triglyceride accumulation relative to untreated mc4r(G894C) controls.

• Dose-dependent attenuation of high-calorie feeding and nicotine-seeking behaviors in multiple behavioral paradigms.

• Modulation of appetite-regulatory leptin and ghrelin gene expression patterns toward wild-type levels.

The publication also discusses limitations associated with currently available obesity therapies and the potential rationale for evaluating differentiated oral therapeutic approaches targeting both metabolic dysregulation and reward-associated behaviors.

Dr. Itzchak Angel, Chief Scientific Advisor at MIRA and corresponding author of the publication, commented:

"The manuscript demonstrates coordinated metabolic and behavioral findings observed with SKNY-1 in a validated preclinical obesity model. We believe these data support continued translational investigation of SKNY-1 and further evaluation of its pharmacological profile in future studies."

The Company noted that the publication describes short-term preclinical findings in zebrafish models and that additional studies, including mammalian studies, pharmacokinetic evaluations, toxicology studies, and regulatory review, will be required before determining whether SKNY-1 may advance toward clinical development.

About SKNY-1

SKNY-1 is an orally administered investigational drug candidate designed to modulate multiple pathways associated with metabolic regulation and reward-associated behaviors. The compound was designed to combine pathway-selective CB1 modulation, CB2 receptor activity, and selective MAO-B inhibition. SKNY-1 has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority, and its safety and efficacy have not been established in humans.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of investigational therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates being evaluated for neuropathic pain(CIPN), inflammatory pain, obesity, addiction-related disorders, anxiety, and cognitive impairment.

For more information, please visit MIRA Pharmaceuticals.

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 can 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, clinical utility, market opportunity, and future development of SKNY-1 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 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 in the Company's under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

We caution investors not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at www.sec.gov and in the "Investors" section of our website at mirapharmaceuticals.com/investors/, for a discussion of these and other risks and uncertainties.

Contact:
Krystina Quintana
[email protected]
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

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(S.Perez--TAG)