The Albany Gazette - MIRA Pharmaceuticals Signs Binding Letter of Intent to Acquire SKNY Pharmaceuticals, Securing a $5 Million Capital Infusion to Advance Weight Loss and Smoking Cessation Drug Development

MIAMI, FL / ACCESS Newswire / March 24, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA"), a clinical-stage pharmaceutical company developing breakthrough therapeutics for neurologic and neuropsychiatric disorders, announced today that it has signed a binding letter of intent (LOI) to acquire SKNY Pharmaceuticals, Inc. The transaction includes a $5 million capital infusion-comprised of cash or equivalent consideration-into MIRA, reinforcing its financial position and supporting the advancement of SKNY-1, a preclinical-stage oral drug candidate for weight loss and smoking cessation.

Under the terms of the LOI, MIRA will acquire SKNY through a stock exchange, whereby SKNY shareholders will receive shares of MIRA common stock at a valuation determined by an independent third-party firm. Additionally, SKNY will contribute $5 million in cash or assets to MIRA at closing. Upon completion, SKNY-1 and all related intellectual property assets will be fully integrated into MIRA, further strengthening MIRA's portfolio of novel therapeutics.

Targeting the Two Leading Causes of Preventable Death
According to a study published in The New England Journal of Medicine, smoking and obesity are the two leading causes of preventable death in the United States. According to the study, smoking is responsible for approximately 18.1% of all deaths, while poor diet and physical inactivity-major contributors to obesity-account for another 16.6%. Despite the burden these conditions place on public health, existing pharmaceutical treatments remain limited, expensive, and often ineffective.

The acquisition of SKNY Pharmaceuticals strategically positions MIRA to enter two high-growth pharmaceutical markets with a differentiated, next-generation oral therapy that has the potential to improve patient outcomes.

Weight Loss: A $150 Billion Market Opportunity
The global weight loss drug market is projected to surpass $150 billion by the early 2030s, fueled by the increasing demand for effective obesity treatments (Source: Reuters). Currently, the market is dominated by GLP-1 receptor agonists like Wegovy and Ozempic, but these drugs present significant limitations, including severe gastrointestinal side effects and the need for lifelong injections. Additionally, insurance reimbursement remains restricted due to the high cost of these products, which limits access to those individuals who need it most.

SKNY-1, which is in preclinical development, is being investigated as a potential oral therapeutic option that may offer an innovative approach to metabolic regulation. The drug candidate is designed to interact with cannabinoid receptors CB1 and CB2 pathways that have been demonstrated for their role in appetite, metabolism, and energy balance regulation. If successful, SKNY-1 could address the growing demand for safe and effective weight loss solutions in a market that continues to expand.

Smoking Cessation: A Nearly $51 Billion Market by 2030
Despite a declining smoking rate, approximately 46 million U.S. adults still use tobacco products, including cigarettes, e-cigarettes, cigars, and smokeless tobacco (Source: PMC). The U.S. smoking cessation market is projected to grow from $28 billion in 2024 to nearly $51 billion by 2030, at a CAGR of 10.4% (Source: Grand View Research).

Current FDA-approved smoking cessation treatments have low efficacy and significant side effects, leading to high discontinuation rates. SKNY-1 is being developed as a potential oral therapy that may work by modulating cannabinoid pathways involved in nicotine dependence. If successful, it could provide an alternative to existing treatments by addressing key challenges in smoking cessation.

CEO Perspective: Strengthening Mira's Market Position and Financial Standing
"Acquiring SKNY Pharmaceuticals marks a transformative step for MIRA," said Erez Aminov, Chairman and CEO of MIRA. "Obesity and smoking remain two of the most pressing public health challenges, yet current treatments have significant limitations. By integrating SKNY-1 into our pipeline, we are expanding into areas of high unmet medical need while strategically positioning MIRA for long-term growth and value creation."

Scientific Perspective: Reviewing the Data and Moving Forward
"After reviewing the preclinical data on SKNY-1, I am excited about the drug's pharmacological profile and its potential to become a game-changer in addressing two of the most urgent public health concerns-obesity and smoking," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "With extensive experience in cannabinoid-based drug development and metabolic research, I see significant promise in SKNY-1's approach to modulating key pathways involved in body weight, metabolic regulation and nicotine dependence."

Next Steps & Closing Conditions
MIRA Pharmaceuticals and SKNY Pharmaceuticals will conduct due diligence during a 90-day period, with both parties working toward executing a definitive agreement. The transaction is subject to regulatory approvals, board approvals, and final due diligence review. Upon closing, SKNY-1 will be fully integrated into MIRA's development pipeline, with plans to accelerate its path toward further preclinical evaluation.

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. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the acquisition transaction and claims regarding SKNY-1. 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. 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 other SEC filings, which are on file with the SEC at www.sec.gov and 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 Information
Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals, Inc.

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