MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) announced today that it has signed a binding letter of intent to acquire SKNY Pharmaceuticals, Inc., in a strategic move that will expand its pipeline with SKNY-1, a preclinical-stage oral drug candidate targeting weight loss and smoking cessation. The transaction includes a $5 million capital infusion into MIRA, strengthening its financial position as it advances development of this novel therapeutic.
Under the terms of the agreement, MIRA will acquire SKNY through a stock exchange, with SKNY shareholders receiving shares of MIRA common stock at a valuation determined by an independent third-party firm. SKNY will contribute $5 million in cash or assets to MIRA at closing, and SKNY-1 along with all related intellectual property will be fully integrated into MIRA's portfolio.
Addressing Two Leading Causes of Preventable Death
The acquisition strategically positions MIRA to target the two leading causes of preventable death in the United States. According to research published in The New England Journal of Medicine, smoking accounts for approximately 18.1% of all deaths in the US, while poor diet and physical inactivity—major contributors to obesity—are responsible for another 16.6%.
"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."
Weight Loss Market: A $150 Billion Opportunity
The global weight loss drug market is projected to surpass $150 billion by the early 2030s, driven by increasing demand for effective obesity treatments. Currently dominated by GLP-1 receptor agonists like Wegovy and Ozempic, the market presents significant opportunities for new entrants that can address the limitations of existing therapies.
Current GLP-1 agonists present several challenges for patients, including severe gastrointestinal side effects and the requirement for lifelong injections. Additionally, limited insurance reimbursement due to high costs restricts access for many patients who could benefit from treatment.
SKNY-1, currently in preclinical development, is being investigated as an oral therapeutic that offers an innovative approach to metabolic regulation. The drug candidate is designed to interact with cannabinoid receptors CB1 and CB2, which play established roles in appetite, metabolism, and energy balance regulation.
Smoking Cessation: Growing to $51 Billion by 2030
Despite declining smoking rates, approximately 46 million U.S. adults still use tobacco products. The U.S. smoking cessation market is projected to grow from $28 billion in 2024 to nearly $51 billion by 2030, representing a compound annual growth rate of 10.4%.
FDA-approved smoking cessation treatments currently suffer from 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, potentially offering an alternative to existing treatments.
Scientific Perspective on SKNY-1
Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, expressed optimism about the acquisition: "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. 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."
Mechanism of Action and Potential Advantages
SKNY-1's approach to targeting cannabinoid receptors represents a different mechanism of action compared to current market leaders. By modulating CB1 and CB2 pathways, the drug candidate aims to regulate appetite and metabolism while potentially addressing nicotine dependence through related neurological pathways.
If successful in clinical development, SKNY-1 could offer several potential advantages over existing therapies, including oral administration instead of injection, potentially fewer gastrointestinal side effects, and a novel mechanism that might prove effective for patients who don't respond to current treatments.
Next Steps in the Acquisition Process
MIRA Pharmaceuticals and SKNY Pharmaceuticals will conduct due diligence during a 90-day period, working toward executing a definitive agreement. The transaction remains 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 and eventual clinical trials. The company has not yet disclosed a specific timeline for initiating clinical studies.
The acquisition represents a significant expansion for MIRA, which has previously focused on developing therapeutics for neurologic and neuropsychiatric disorders. By entering the weight loss and smoking cessation markets, MIRA is diversifying its portfolio while leveraging potential synergies in cannabinoid-based drug development.
As obesity rates continue to rise globally and smoking remains a significant public health challenge, the demand for effective, well-tolerated treatments continues to grow. MIRA's acquisition of SKNY Pharmaceuticals positions the company to potentially address these major health concerns with an innovative approach that could overcome limitations of current therapies.
