Latest news with #SKNY
Miami Herald
25-06-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Announces New Data Underscoring Potential of SKNY-1 - A Drug Candidate Pending Acquisition - To Disrupt Weight Loss and Smoking Cessation Markets Without CNS Side Effects
MIAMI, FL / ACCESS Newswire / June 25, 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 new in vitro preclinical data generated by Eurofins supporting the therapeutic potential of SKNY-1, a next-generation oral drug candidate being developed by SKNY Pharmaceuticals, Inc. ("SKNY"). MIRA has signed a definitive agreement to acquire SKNY, and the proposed transaction remains subject to regulatory review and shareholder approval. SKNY-1 is being developed to help individuals lose weight and quit smoking by targeting key biological pathways involved in appetite, addiction, and reward-without triggering the central nervous system (CNS) side effects that have historically limited cannabinoid-based therapies. "We believe SKNY-1 could be a first-in-class oral therapy for two of the largest and most underserved markets: obesity and nicotine addiction," said Erez Aminov, CEO of MIRA. "What makes this drug candidate so exciting is its precision-it's engineered to avoid the psychiatric side effects that doomed earlier drugs in this class, while offering a safe, convenient, once-daily oral option." Designed for Selectivity and SafetyPrevious CB1-targeting drugs, such as rimonabant (Acomplia®, Sanofi), showed weight loss and metabolic results but were ultimately withdrawn from the market due to serious psychiatric side effects, including depression and suicidal ideation.¹ These effects stemmed from non-selective inhibition of CB1 signaling in the brain. In contrast, in vitro studies conducted by Eurofins demonstrated that SKNY-1 acts as a biased CB1 modulator-selectively blocking the β-arrestin signaling pathway, which is associated with cravings and compulsive behavior, while preserving G-protein signaling, which is important for emotional and cognitive stability. This selective mechanism is designed to reduce cravings and body weight without disrupting mood. A Dual Receptor Strategy-Engaging CB2 for Metabolic SupportIn addition to CB1 modulation, SKNY-1 also interacts with the CB2 receptor, which plays a critical role in metabolic regulation and inflammation. Eurofins' in vitro data show that SKNY-1 behaves as a partial CB2 agonist, potentially enhancing fat metabolism, reducing peripheral inflammation and improving insulin sensitivity. This dose-dependent flexibility distinguishes SKNY-1 from earlier CB1-only drugs and may enable a broader therapeutic impact on obesity-related pathways. "SKNY-1 combines modern pharmacology with real-world practicality," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "By precisely modulating CB1 and CB2 and supporting dopamine stability, it targets obesity and addiction through multiple, complementary mechanisms while potentially avoiding cannabinoid-related psychiatric side-effects." Dopamine Stability Without Stimulant RiskSKNY-1 also mildly inhibits the MAO-B enzyme, helping regulate dopamine, a neurotransmitter involved in motivation, focus, and reward. Unlike older monoamine inhibitors, SKNY-1 does not inhibit MAO-A, reducing the risk of serotonin-related side effects. Importantly, the compound demonstrated no or minimal antagonist binding to dopamine receptors (D1, D2, D3), further supporting its favorable CNS safety profile. A Differentiated Alternative to InjectablesWhile injectable GLP-1 drugs have gained market attention, they are often associated with gastrointestinal side effects and muscle loss. SKNY-1 is being developed as an oral therapy with a profile and expected mechanism that may help preserve muscle mass and improve patient adherence by avoiding injections. Market Outlook and Strategic FitObesity and smoking remain two of the world's leading causes of preventable death. The global obesity drug market is projected to surpass $150 billion in value by 2030, and the U.S. smoking cessation market is forecast to grow from $28 billion in 2024 to over $50 billion by decade's end. Pending the completion of the proposed acquisition, MIRA believes SKNY-1 could become a cornerstone asset within its pipeline, offering a next-generation solution to two major health challenges. The Company is currently finalizing animal data related to weight loss and nicotine addiction, which will further support its development strategy and future regulatory filings. MIRA has submitted the required regulatory filings to the U.S. Securities and Exchange Commission (SEC) in connection with the proposed acquisition of SKNY. A shareholder vote will follow in accordance with SEC regulations. For more information, please visit: About MIRA Pharmaceuticals, Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as anxiety, cognitive decline, neuropathic pain, obesity, and addiction. Cautionary Note Regarding Forward-Looking StatementsThis 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 and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Footnote:¹ European Medicines Agency. "Acomplia Suspended as Risks Outweigh Benefits." October 23, 2008. CONTACT:Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Miami Herald
28-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical Program
The company will engage in BIO One-on-One Partnering™ meetings as it advances Phase 1 for Ketamir-2, prepares Phase IIa study in neuropathic pain, and finalizes filings for SKNY acquisition. MIAMI, FL / ACCESS Newswire / May 28, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that it will participate in the BIO International Convention 2025, taking place in Boston, MA from June 16-19, 2025. The Company has a full schedule of BIO One-on-One Partnering™ meetings planned as it explores potential licensing, strategic partnerships, and M&A opportunities. The Company's lead candidate, Ketamir-2, a next-generation oral ketamine analog, is currently undergoing a Phase 1 clinical trial. With the second dosing cohort completed, the Company is now preparing to initiate the third cohort. Building on this momentum, MIRA anticipates initiating a Phase IIa study in neuropathic pain before the end of the year, advancing the development of what the Company believes could be a safe, effective non-opioid alternative for chronic pain management. In addition, MIRA is advancing a series of preclinical studies with Ketamir-2, including models evaluating its potential in PTSD, as well as a topical formulation aimed at treating localized inflammatory pain. The Company is also finalizing regulatory filings related to its acquisition of SKNY Pharmaceuticals, Inc. ("SKNY"), with submission to the U.S. Securities and Exchange Commission (SEC) expected in the coming weeks. SKNY-1, SKNY's primary pharmaceutical candidate, is being developed as an oral therapeutic targeting smoking cessation and obesity, with activity at CB1, CB2, and MAO-B receptors. "Our pipeline is advancing on all fronts, and we are focused on turning this scientific momentum into long-term value for patients and shareholders," said Erez Aminov, Chief Executive Officer of MIRA. "As we move closer to initiating Phase IIa and completing the SKNY transaction, we're actively exploring strategic opportunities to accelerate growth, including licensing and partnerships-especially in areas like chronic pain where non-opioid alternatives like Ketamir-2 are urgently needed." Dr. Angel, Chief Scientific Advisor at MIRA, added:"We believe Ketamir-2 is paving the way for a new class of non-opioid therapies. The science is compelling, and the progress we have made is truly exciting. I look forward to sharing the depth of our work and the promising data we've generated with potential partners and investors." Cautionary Note Regarding Forward-Looking StatementsThis 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 other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact InformationHelga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Miami Herald
08-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Announces Board Approval of SKNY Acquisition Reflecting $60+ Million in Combined Enterprise Value Based on Independent Review
With valuations confirmed by the board, MIRA advances strategic acquisition targeting obesity and nicotine dependence, which includes a $5 million contribution in cash or assets from SKNY to be transferred at closing. MIAMI, FLORIDA / ACCESS Newswire / May 8, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, Inc. (the "Merger"), following the completion of independent valuation reports on both companies. The Merger remains subject to MIRA and SKNY's shareholder approval. A third-party analysis conducted by Moore Financial Consulting ("Moore") assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5 million, based on a risk-adjusted net present value (rNPV) of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30 million, further validating the strength and synergy of the combined pipeline. As outlined in the previously announced binding letter of intent for the merger between MIRA and SKNY-1, upon the closing, SKNY must hold at least $5 million in cash or other assets, to be transferred at closing, and the Company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. As MIRA advances this merger, the combined enterprise value (based on Moore's valuations) of over $60 million represents a strong platform for expansion into high-value therapeutic markets. According to MIRA CEO Erez Aminov, the acquisition "brings together two pipelines, two market opportunities, and one unified strategy, developing targeted, first-in-class therapies for urgent public health needs." Targeting Major Markets with a Differentiated Mechanism SKNY-1 is being developed as a next-generation oral therapeutic designed to modulate CB1 and CB2 cannabinoid receptors, as well as monoamine oxidase B (MAO-B)-an enzyme involved in dopamine metabolism and addiction regulation. This multi-target mechanism is being evaluated for its potential to address both metabolic dysfunction and nicotine dependence, providing a differentiated therapeutic alternative in two of the most urgent health markets globally. The global weight loss drug market is projected to surpass $150 billion by 2030, driven by growing demand for safer and more tolerable alternatives to GLP-1-based injectables (Source: Reuters).The U.S. smoking cessation market is projected to grow from $28.11 billion in 2024 to $50.90 billion by 2030, at a CAGR of 10.4% (Source: Grand View Research). These are large, underserved markets with limited innovation, and MIRA's leadership believes the addition of SKNY-1 to the Company's pipeline enhances its ability to compete in both. Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, noted that SKNY-1's pharmacological profile, particularly its combined activity on both MAO-B and cannabinoid receptors, makes it a unique and promising candidate for craving, addiction and metabolic conditions with a sound neurochemical basis. "From a scientific perspective, this is a rationally designed molecule that addresses the biological complexity of both obesity and addiction," said Dr. Angel. "The early data are promising, and I'm looking forward to advancing its development." Strategic Value for the Future With both companies independently valued by Moore at approximately $30 million, MIRA believes this transaction creates a platform with scale, differentiated science, and a pipeline built to target urgent unmet needs. The Company views this merger as a foundation for long-term growth and innovation. Additional information about MIRA Pharmaceuticals is available at 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 other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Yahoo
24-03-2025
- Business
- Yahoo
EXCLUSIVE: MIRA Pharmaceuticals Signs To Acquire SKNY Pharmaceuticals, Expand Pipeline Into Weight Loss And Smoking Cessation Drug
On Monday, MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) signed a binding letter of intent (LOI) to acquire SKNY Pharmaceuticals, Inc. The transaction includes a $5 million capital infusion 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. Also Read: Under the terms, 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. The acquisition of SKNY Pharmaceuticals strategically positions MIRA to enter two high-growth pharmaceutical markets with a differentiated, next-generation oral therapy. SKNY-1, in preclinical development, is being investigated as a potential oral therapeutic option for 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. 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. Last week, MIRA Pharmaceuticals announced the formulation of Ketamir-2 as a topical treatment for localized neuropathic and inflammatory pain. The advancement expands the company's pain management portfolio beyond its ongoing Ketamir-2 oral treatment for neuropathic pain. Price Action: MIRA stock is trading lower by 3.12% to $1.24 premarket at the last check on Monday. Read Next:Up Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market. Get the latest stock analysis from Benzinga? This article EXCLUSIVE: MIRA Pharmaceuticals Signs To Acquire SKNY Pharmaceuticals, Expand Pipeline Into Weight Loss And Smoking Cessation Drug originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Sign in to access your portfolio
