MIRA Pharmaceuticals Shareholders Approve Acquisition of SKNY Pharmaceuticals, Advancing Next-Generation Oral Therapeutic for Obesity and Smoking Cessation

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SKNY transaction strengthens MIRA pipeline with SKNY-1, a differentiated oral candidate that has demonstrated up to 30% weight loss and nicotine craving reversal in preclinical studies.

MIAMI, FL / ACCESS Newswire / September 12, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that its stockholders have approved the acquisition of SKNY Pharmaceuticals, Inc. ("SKNY") at the Company's 2025 Annual Meeting of Stockholders.

All proposals at the meeting were approved by shareholders, including the SKNY acquisition. The Company expects the transaction to close shortly, subject to customary closing conditions.

Transaction Terms and Valuation

Under the terms of the definitive agreement, the acquisition will be structured as a share exchange, with SKNY shareholders receiving shares of MIRA common stock in exchange for their SKNY shares.

At closing, SKNY shall contribute an amount of assets or cash (or a combination of the two) totaling $5,000,000 to MIRA, reinforcing the Company's financial position.

Independent third-party valuation analyses conducted by Moore Financial Consulting assigned an enterprise value of approximately $30.5 million to SKNY (based on a risk-adjusted net present value of SKNY-1) and $30 million to MIRA, supporting a combined enterprise value of more than $60 million for the merged entity.

SKNY-1: A Differentiated Oral Approach to Obesity and Addiction

SKNY-1 is a next-generation oral drug candidate designed to target the endocannabinoid system with precision, modulating CB1 and CB2 receptors and MAO-B to address appetite, reward, and craving-without the psychiatric side effects that halted earlier CB1-targeting drugs.

Key preclinical results include:

• Up to 30% body weight reduction in animal models, with preservation of muscle mass.

• Reversal of nicotine craving and high-calorie food cravings, supporting its potential as a dual-indication therapy.

• Reversal of CB1-induced anxiety-like behavior in validated animal models, suggesting improved CNS safety compared with earlier agents.

• Mechanistic studies conducted by Eurofins demonstrated that SKNY-1 selectively blocks β-arrestin signaling of CB1 receptors while sparing G-protein signaling, a design intended to reduce food intake and body weight without destabilizing mood.

"We believe SKNY-1 could be a best-in-class oral therapy for two of the leading causes of preventable death-obesity and nicotine addiction. Our shareholders' approval is a major milestone that positions us to close the SKNY acquisition and advance this program toward IND-enabling studies," said Erez Aminov, Chief Executive Officer of MIRA.

Market Opportunity

• The global obesity therapeutics market is projected to surpass $150 billion by the early 2030s ( Reuters ).

• The U.S. smoking cessation market is forecast to grow from $28 billion in 2024 to approximately $50.9 billion by 2030 ( Grand View Research ).

By combining differentiated pharmacology, oral delivery, and dual efficacy across obesity and addiction, SKNY-1 may offer a compelling profile for these high-value, underserved markets.

Scientific Perspective

"SKNY-1 has a unique profile with biased CB1 signaling and unique CB2 profile, and our preclinical data now confirm it can reduce cravings, lower weight and metabolic parameters, and reverses CB1-agonist induced anxiety-addressing the very limitations that halted earlier drugs in this class," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA.

Cautionary Note Regarding Forward-Looking Statements

This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact:

Helga Moya

[email protected]

(786) 432-9792

SOURCE: MIRA Pharmaceuticals