DEFM14A: MIRA Pharma to Merge with SKNY, Expanding Pipeline

MIRA Pharmaceuticals seeks stockholder approval for a merger with SKNY Pharmaceuticals, creating a biopharma company focused on novel therapeutics for smoking cessation, obesity, pain, and cognitive impairment.

Summary

• MIRA Pharmaceuticals, Inc. (MIRA) is holding a virtual annual meeting on September 11, 2025, to seek stockholder approvals for a merger with SKNY Pharmaceuticals, Inc. (SKNY).
• The merger will create a biopharmaceutical company focused on developing novel product candidates for smoking cessation, obesity, pain management, depression, PTSD, and cognitive impairment.
• Post-merger, pre-Merger equity holders of MIRA and SKNY are each expected to hold approximately 50% of the outstanding shares of the combined company on a fully diluted basis.
• MIRA's board of directors unanimously recommends voting FOR all proposals, including the merger.
• SKNY must hold at least $5 million in cash or marketable securities as a condition to closing.
• MIRA's current stock price was $1.75 per share on July 22, 2025.
• The Exchange Ratio is 1:1, based on Moore Financial Consulting valuations of SKNY at $30.5 million and MIRA at $30 million.
• SKNY's lead candidate, SKNY-1, is a preclinical-stage oral therapeutic targeting cannabinoid receptors CB1/CB2 and MAO-B inhibition for weight loss and smoking cessation.
• MIRA's pipeline includes Ketamir-2 (oral ketamine analog for diabetic neuropathic pain, Phase I) and MIRA-55 (THC analog for cognitive function and inflammatory pain, preclinical).
• Both Ketamir-2 and MIRA-55 have been determined by the DEA not to be controlled substances.
• The global weight loss drug market is estimated at $24.6 billion for 2025, projected to reach $131 billion by 2028.
• The global smoking cessation market is estimated at $25.5 billion in 2024, projected to reach $53.87 billion to $71.5 billion by 2030-2034.

Sentiment

Score: 7

Explanation: The merger presents significant strategic opportunities for pipeline expansion and market entry into high-growth therapeutic areas. However, it also introduces substantial risks associated with early-stage drug development, SKNY's limited operating history, and potential conflicts of interest, which temper the overall positive sentiment.

Positives

• The merger expands MIRA's product offering into new markets (smoking cessation, obesity) with SKNY-1.
• SKNY-1 has a unique profile as a CB1 blocker, CB2 activator, and selective MAO-B inhibitor, potentially offering improved efficacy without certain side effects.
• MIRA's existing candidates, Ketamir-2 and MIRA-55, are not classified as controlled substances, which is expected to streamline their development.
• The combined company is expected to possess sufficient financial resources, including SKNY contributing at least $5 million in cash/marketable securities.
• The merger provides an opportunity for MIRA stockholders to participate in the potential growth of the combined enterprise.
• MIRA's board believes the Exchange Ratio is favorable for MIRA stockholders based on Moore's valuation.
• The post-Merger company will continue to trade on Nasdaq under the symbol MIRA.

Negatives

• SKNY has a limited operating history and no revenues to date, expecting significant losses into the foreseeable future.
• SKNY has significant and increasing liquidity needs and will require additional funding, which will be increased by SKNY's operations post-merger.
• SKNY does not own rights to SKNY-1; all rights are under a license from MIRALOGIX LLC, subject to an 8% royalty on all revenue and a minimum annual royalty of $250,000.
• Conflicts of interest may arise due to overlapping ownership and licensing agreements between MIRA, SKNY, and MIRALOGIX LLC, which is owned by Bay Shore Trust (also SKNY's largest stockholder and a significant MIRA shareholder).
• The market price of MIRA Common Stock is subject to fluctuations and may decline as a result of the merger and share issuance.
• The issuance of MIRA Common Stock to SKNY stockholders could depress MIRA's market price.
• The combined company may be subject to the Investment Company Act of 1940 if it holds Telomir Pharmaceuticals, Inc. shares, requiring their sale within one year.

Risks

• SKNY has a limited operating history, making it difficult to accurately evaluate its operations.
• SKNY is an early development-stage company with no revenues and expects to incur significant losses, requiring additional funding.
• Operating results of the combined company may vary significantly due to product development objectives, clinical trial expenses, and timing of payments.
• SKNY's ability to generate revenue depends on regulatory approval of its product candidates, which will take years and may not be obtained.
• SKNY does not own the rights to SKNY-1; its rights are granted under a license from MIRALOGIX LLC, which could be lost if SKNY breaches the agreement or MIRALOGIX goes bankrupt.
• SKNY's rights to SKNY-1 are subject to an 8% royalty on all revenue and a minimum annual royalty of $250,000 to MIRALOGIX LLC.
• Conflicts of interest may arise between SKNY and MIRALOGIX LLC due to common ownership and licensing agreements.
• SKNY's product candidates, if approved, may not achieve expected market acceptance, limiting revenue generation.
• If prices for future approved products decrease or if third-party payers do not provide adequate coverage and reimbursement, revenue and profitability will suffer.
• SKNY expects intense competition from companies with greater resources and experience.
• Future viability depends largely on the positive development of SKNY-1 and other candidates, requiring significant capital and years of clinical effort.
• SKNY has limited marketing experience and does not anticipate establishing a sales force, potentially hindering commercialization.
• There is no assurance when or if the merger will be completed, as it is subject to various conditions, including SKNY having $5 million in cash/marketable securities.
• The lack of a public market for SKNY Common Stock makes it difficult to determine its fair market value.
• SKNY may fail to expand manufacturing capability or meet FDA acceptance for facilities.
• Product liability lawsuits could result in substantial liabilities and limit commercialization.
• Legislative or regulatory reform of the U.S. healthcare system may affect profitability.
• Unfavorable global economic and geopolitical conditions could adversely affect the business.
• Clinical trials are expensive, time-consuming, uncertain, and susceptible to delays or termination.
• Litigation relating to the transaction may be filed, resulting in costs or delays.
• If MIRA is determined to be an investment company under the U.S. Investment Company Act of 1940, applicable restrictions could make it impractical to continue business.
• MIRA may not be able to effectively integrate SKNY's development activities or manage the combined business, and anticipated synergies may not be realized.
• Uncertainties associated with the merger may cause a loss of management personnel and other key employees.
• MIRA will incur significant transaction and integration-related costs.
• The market price of MIRA Common Stock may decline as a result of the merger and the issuance of shares.

Future Outlook

The combined company will focus on developing and commercializing novel, potentially first-in-class product candidates across multiple therapeutic areas. MIRA anticipates the merger to be consummated in Q3 2025, and plans to initiate Phase 2a studies for Ketamir-2 in neuropathic pain patients in Q4 2025. The company expects to leverage its public company structure and SKNY's drug candidates to raise additional funds.

Management Comments

• MIRA is excited about the opportunities the Merger brings to its stockholders, and thanks you for your consideration and continued support.
• The MIRA Board has unanimously determined and believes that each of the proposals outlined above is advisable to, and in the best interests of, MIRA and its stockholders and has unanimously approved each such proposal. The MIRA Board unanimously recommends that MIRAs stockholders vote FOR each such proposal.

Industry Context

The merger positions MIRA to capitalize on the rapidly growing markets for weight loss and smoking cessation, which are significant global health challenges. SKNY-1's unique multi-target mechanism (CB1 blocker, CB2 activator, MAO-B inhibitor) aims to differentiate it from existing GLP-1 agonists (e.g., Wegovy, Zepbound) and traditional smoking cessation aids (e.g., Chantix, Zyban) by potentially offering improved efficacy and addressing post-cessation weight gain. MIRA's existing neuroscience pipeline (Ketamir-2 for DNP, MIRA-55 for MCI) also targets areas with substantial unmet medical needs and growing market sizes, aligning with broader trends in biopharmaceutical innovation for chronic and neurodegenerative conditions.

Comparison to Industry Standards

• SKNY-1 aims to offer superior efficacy to other oral anti-obesity medications while improving safety and tolerability, addressing key concerns and improving compliance, differentiating from current GLP-1 agonists like Eli Lilly's Zepbound (Tirzepatide) and Novo Nordisk's Wegovy (semaglutide) which have shown significant weight loss but may have side effects or supply constraints.
• SKNY-1's dual-pathway strategy for smoking cessation, including mitigating post-cessation weight gain, addresses an unmet need not adequately covered by currently approved therapies like Pfizer's Chantix (Varenicline) and GlaxoSmithKline's Zyban (Bupropion), which have known side effects.
• The valuation methodology used by Moore Financial Consulting (rNPV analysis) is suited for preclinical and clinical stage biotech assets, aligning with industry standards for valuing novel pharma and biotech drugs undergoing phased development.
• The success rates for clinical trials used in the valuation are based on research performed and published by the Biotechnology Innovation Organization (BIO), reflecting industry benchmarks for drug development probabilities.

Management Changes

Corporate Governance

Legal Proceedings

• No legal proceedings, government actions, administrative actions, investigations, or claims are currently pending against SKNY that are expected to have a material adverse effect.
• No legal proceedings, government actions, administrative actions, investigations, or claims are currently pending against MIRA or Merger Sub that are expected to have a material adverse effect or prevent/delay the merger.
• Potential for stockholder lawsuits against the MIRA Board related to the merger, which could result in substantial costs or delays.

Related Party Transactions

• MIRA's CEO, Erez Aminov, holds 19.23% of MIRA and 13.6% of SKNY.
• MIRA's director, Dr. Denil Shekhat, holds under 1.0% of SKNY and is trustee of the 2023 YEA Irrevocable Trust, which holds 2,739,000 shares of SKNY.
• Bay Shore Trust holds 2,540,270 shares of MIRA, 1,000,000 MIRA warrants, and 7,128,532 shares (32.3%) of SKNY. Bay Shore Trust also owns MIRALOGIX LLC.
• The Celeste J Williams Lifetime QTIP Trust holds 779,047 shares of MIRA and 576,150 shares (2.6%) of SKNY.
• MIRALOGIX LLC licenses intellectual property (SKNY-1 for SKNY, Ketamir-2 for MIRA) to both MIRA and SKNY, with royalty payments due to MIRALOGIX.
• MIRA and Telomir Pharmaceuticals, Inc. (Nasdaq: TELO) share the same executive officers and a majority of board members. Bay Shore Trust also owns 5,406,431 shares of Telomir.
• MIRA will become the beneficial owner of approximately 6.67% of Telomir Pharmaceuticals, Inc. upon acquiring SKNY.
• MIRA's Board adopted an Executive Compensation Plan with performance-based compensation for executive officers tied to the successful completion and overall value of the Merger.

Stakeholder Impact

• Shareholders (MIRA): Will vote on the merger and other proposals. Expected to hold 50% of the combined company. Potential for value creation through expanded pipeline but also risks of dilution and market price volatility.
• Shareholders (SKNY): Will receive MIRA Common Stock, expected to hold 50% of the combined company. Their shares will be converted into MIRA stock.
• Employees (MIRA & SKNY): Uncertainty about roles post-merger could lead to loss of key personnel. Management team of MIRA is expected to remain the same, with SKNY's CEO joining the board.
• Customers/Patients: Potential for new therapeutic options in smoking cessation, obesity, pain management, depression, PTSD, and cognitive impairment if product candidates are successfully developed and approved.
• MIRALOGIX LLC: Will continue to receive royalty payments from both MIRA and SKNY for licensed intellectual property.

Next Steps

• MIRA stockholders to vote on five proposals at the Annual Meeting on September 11, 2025, including approval of the merger.
• Consummation of the Merger is anticipated during the third quarter of 2025.
• MIRA to initiate Phase 2a studies for Ketamir-2 in neuropathic pain patients in Q4 2025.
• SKNY to continue preclinical development for SKNY-1, leading to an Investigational New Drug (IND) application submission.
• SKNY plans to conduct Phase 1 (safety, tolerability, PK) and Phase 2 (proof-of-concept in smokers) clinical trials for SKNY-1.
• The combined company will need to raise additional capital to fund operations and clinical trials.
• MIRA's Board is required to sell shares of Telomir Pharmaceuticals, Inc. within one year following the Merger to comply with ICA Rule 3-a2.
• Final voting results will be published in a current report on Form 8-K within four business days after the Annual Meeting.

Key Dates

Recommendation

The proposed merger offers MIRA a significant opportunity to diversify and expand its drug development pipeline into high-growth therapeutic areas like obesity and smoking cessation, leveraging SKNY's preclinical asset SKNY-1. This strategic move, coupled with MIRA's existing neuroscience programs (Ketamir-2 in Phase I, MIRA-55 in preclinical), could create long-term value. However, the combined entity faces substantial risks inherent in early-stage biopharmaceutical development, including the high costs and uncertainties of clinical trials, intense competition, and the need for significant future funding. Furthermore, the disclosed related-party transactions and licensing agreements, while common in early-stage ventures, introduce potential conflicts of interest that warrant careful monitoring. The 50/50 equity split and the requirement for SKNY to bring $5 million in assets are structured to balance the deal. Given the early stage of SKNY's assets and the execution risks involved in integrating two development-stage companies, a 'hold' recommendation is appropriate. Investors should monitor clinical trial progress, regulatory approvals, and the successful integration of SKNY's operations, as these will be critical determinants of future value.

Keywords

Biopharmaceutical, Merger, SEC Filing, Nasdaq, Clinical Trials, Drug Development, Smoking Cessation, Obesity, Pain Management, PTSD, Cognitive Impairment, Ketamine Analog, THC Analog, SKNY-1, Ketamir-2, MIRA-55, Pharmaceutical Industry, Corporate Governance, Risk Factors, Shareholder Vote