Core Insights - The company achieved positive preclinical study results for Ketamir-2, a novel oral ketamine analog, which were characterized as "highly encouraging" [2][5] - Ketamir-2 demonstrated significant improvements in locomotor activity, travel speed, and reduced anxiety levels in treated mice [2][3] - The company aims to submit an Investigational New Drug (IND) application to the FDA for Ketamir-2 by the end of the year [5] Preclinical Study Results - In the Open Field Test (OFT), mice treated with Ketamir-2 showed reduced swimming distances and speed, indicating an antidepressant effect [8] - The Elevated Plus Maze (EPM) results indicated that Ketamir-2 treated mice spent more time in open arms, suggesting reduced anxiety [3][8] - The Forced Swim Test (FST) revealed significantly reduced immobility times in mice treated with Ketamir-2, highlighting its potential antidepressant properties [4] Company Overview - MIRA Pharmaceuticals is a preclinical-stage pharmaceutical company focused on developing a new synthetic cannabinoid analog for treating neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia [7] - The company has acquired rights to Ketamir, a potential derivative of ketamine, which may have fewer side effects and a faster onset of action compared to existing treatments [7] Market Potential - The positive results from the preclinical studies are expected to validate the potential benefits of Ketamir-2, positioning it as a safer and more effective option for treating depression in home settings [5] - The company is focusing on Ketamir-2 due to its potential for rapid market entry, which could attract significant investor interest [10]

Core Insights - MIRA Pharmaceuticals is preparing to submit an Investigational New Drug Application (IND) for Ketamir-2 to the FDA later this year, aiming to initiate human clinical trials [1][2] - The preclinical trials have shown promising results for Ketamir-2, indicating its efficacy and improved safety profile compared to traditional ketamine, which could provide a new treatment option for patients with depression and treatment-resistant depression (TRD) [2][14] Company Overview - MIRA Pharmaceuticals, Inc. is a pre-clinical-stage pharmaceutical development company focused on treating neurologic and neuropsychiatric disorders, holding exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico [10] - The company is also investigating MIRA-55, a novel oral pharmaceutical marijuana analog, for treating neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia [3] Study Findings - The study conducted by Pharmaseed Ltd. evaluated the anti-depressive and anxiolytic effects of Ketamir-2 compared to traditional ketamine using behavioral tests in male mice [15] - Key findings from the study include: - In the Open Field Test (OFT), mice treated with Ketamir-2 showed significantly greater locomotor activity and reduced anxiety levels [12] - In the Elevated Plus Maze (EPM), treated mice exhibited increased travel distance and time spent in open arms, indicating reduced anxiety [12] - In the Forced Swim Test (FST), Ketamir-2 treatment resulted in reduced swimming distances and immobility times, highlighting its potential antidepressant properties [12] Future Directions - MIRA Pharmaceuticals is optimistic about the potential of Ketamir-2 as a safer and more effective treatment option for depression, with ongoing studies evaluating its efficacy in treating post-traumatic stress syndrome and neuropathic pain [16][13] - The U.S. Drug Enforcement Administration's review concluded that Ketamir-2 is not a controlled substance, which may facilitate its development and approval process [10][8]

Core Viewpoint - MIRA Pharmaceuticals, Inc. announced that its product MIRA-55 is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA), which facilitates its development and commercialization in treating neurologic and neuropsychiatric disorders [2][7][9]. Group 1: Product Overview - MIRA-55 is being investigated for treating adult patients with neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia [3][9]. - Pre-clinical studies indicate that MIRA-55 can improve memory by 100% in wild-type mice, contrasting with THC, which can impair cognitive function [3][4]. Group 2: Market Potential - The company estimates a significant market opportunity with access to a $90 billion traditional neurological market and a $30 billion cannabis market [5]. - Anxiety disorders affect approximately 40 million U.S. adults, while cognitive impairment impacts around 16 million people, indicating a substantial patient population for MIRA-55 [5]. Group 3: Competitive Advantages - MIRA-55 offers a more stable anti-anxiety effect compared to THC, which has a biphasic effect [7]. - The product exhibits lower potency at the CB1 receptor, responsible for psychoactive effects, while maintaining higher activation of the CB2 receptor, suggesting therapeutic benefits with minimal intoxicating effects [7]. - MIRA-55 aims to provide quicker relief and fewer side effects compared to current treatments like SSRIs and SNRIs, which can take weeks to show effects [5][7]. Group 4: Regulatory Status - The DEA's ruling on MIRA-55 provides a regulatory advantage, allowing for more accessible research and development processes compared to marijuana, which is classified as a controlled substance [7][9]. - MIRA Pharmaceuticals also holds exclusive rights for Ketamir-2, another product not classified as a controlled substance, indicating a favorable regulatory environment for its pipeline [8].

Core Viewpoint - MIRA Pharmaceuticals is advancing its novel oral ketamine analog, Ketamir-2, in collaboration with Memorial Sloan Kettering Cancer Center to evaluate its effectiveness in managing cancer pain and associated depression [1][2][4]. Company Overview - MIRA Pharmaceuticals is a pre-clinical-stage pharmaceutical company focused on neurologic and neuropsychiatric disorders, holding exclusive rights for Ketamir-2 in the U.S., Canada, and Mexico [9]. - The company is also developing MIRA-55, a novel oral pharmaceutical marijuana for treating anxiety and cognitive decline [10]. Collaboration with Memorial Sloan Kettering - The partnership with MSK aims to validate Ketamir-2's potential and broaden its applications beyond treatment-resistant depression and PTSD [2][4]. - MSK currently uses intravenous ketamine for refractory cancer pain, and the oral formulation of Ketamir-2 could offer a safer, more convenient alternative [3][5]. Clinical Development and Market Potential - The collaboration will assess Ketamir-2's efficacy in a rodent model for cancer pain, potentially streamlining the regulatory approval process for clinical trials [6]. - Successful preclinical outcomes could accelerate the FDA approval pathway for Ketamir-2, enhancing MIRA's capacity to deliver innovative treatments [6]. Cancer Pain Statistics - Approximately 44% of cancer patients experience pain, with 31% suffering from moderate to severe pain [8]. - Around 25% of cancer patients also suffer from depression, significantly higher than the general population [8].

Core Viewpoint - MIRA Pharmaceuticals is advancing the development of Ketamir-2, an oral ketamine analog, for the treatment of PTSD, depression, and neuropathic pain, with preclinical studies underway and plans for human testing in 2025 [1][2][9]. Group 1: Preclinical Studies and Development - MIRA has initiated preclinical trials in collaboration with Pharmaseed to evaluate Ketamir-2's efficacy against ketamine in a rat model of severe PTSD, focusing on chronic stress and fear memory processing [3]. - A head-to-head study with Biotrial will assess the locomotor activity effects of Ketamir-2 compared to ketamine, providing insights into its pharmacodynamics and potential side effects [4]. - MIRA has also started 7-day toxicology studies in rats and dogs with Frontage Laboratories, which are essential for ensuring the safety and efficacy of Ketamir-2 before human trials [5]. Group 2: Manufacturing and Regulatory Progress - Significant advancements have been made in the manufacturing process of Ketamir-2, optimizing the synthetic process and reducing production costs, which is crucial for scaling up under Good Manufacturing Practices (GMP) [6]. - MIRA anticipates submitting an Investigational New Drug Application (IND) to the FDA by the end of this year, contingent on positive preclinical results [2]. Group 3: Market Potential and Therapeutic Applications - PTSD affects approximately 8 million adults annually in the U.S., with current treatments often providing limited relief, highlighting the potential market for Ketamir-2 as a safer and more effective alternative [7]. - The U.S. market for PTSD treatments is projected to reach $26 billion by 2031, indicating significant growth potential for Ketamir-2 [9]. - MIRA is exploring collaborations with research centers to study Ketamir-2's efficacy in treating cancer pain, which could broaden its therapeutic applications [8]. Group 4: Management Insights - The management emphasizes the importance of these preclinical trials in addressing severe mental health disorders and neuropathic pain, with a focus on the financial impact of treatment-resistant depression in the U.S., estimated at $92.7 billion annually [9]. - The unique properties of Ketamir-2, including high oral bioavailability and lack of mu opioid interaction, position it as a promising option for rapid relief from depression in a home setting [9].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________to _______________ Commission file number 001-41765 MIRA Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Florida 85-3 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 MIRA Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Florida 85-3354547 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 1200 Brickell Avenue, Suite 1950 #1183, Miami, Florida 33131 (Address of principal executive offic ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Florida 85-3354547 (State or other jurisdiction of incorporation or organization) 855 N Wolfe Street, Suite 601 Baltimore, Maryland 21205 (Address of principal executive offices) (Zip Code ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______________to _______________ Commission file number 001-41765 MIRA Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) Florida 85-33 ...